Multiple anchor delivery tool

ABSTRACT

An anchor deployment tool is provided that includes a flexible tube, which defines an anchor storage area in which tissue anchors are stored before deployment, and a distal anchor manipulation area that has a length of at least 3 cm. The tool also includes a rotating deployment element, which is positioned within the flexible tube, and is configured to, while the distal anchor manipulation area is disposed within a lumen defined by a wall of a sleeve, (i) directly engage the anchors in the anchor storage area a single one at a time, (ii) advance each of the anchors, while thus directly engaged, in a distal direction into the anchor manipulation area, and (iii) anchor the sleeve to tissue of a subject by deploying each of the tissue anchors through a distal end of the flexible tube, through the wall of the sleeve, and into the tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.13/749,153, filed Jan. 24, 2013, which is:

(a) a continuation-in-part of U.S. application Ser. No. 12/437,103,filed May 7, 2009, now U.S. Pat. No. 8,715,342; and

(b) a continuation-in-part of International Appl. No. PCT/IL2011/000600,filed Jul. 26, 2011, which published as PCT Publication WO 2012/014201,which is a continuation-in-part of U.S. application Ser. No. 12/843,412,filed Jul. 26, 2010, now U.S. Pat. No. 8,523,881.

All of the above-mentioned applications are assigned to the assignee ofthe present application and are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates in general to valve repair, and morespecifically to repair of an atrioventricular valve of a patient.

BACKGROUND OF THE INVENTION

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus. Dilation of the annulus of the mitral valveprevents the valve leaflets from fully coapting when the valve isclosed. Mitral regurgitation of blood from the left ventricle into theleft atrium results in increased total stroke volume and decreasedcardiac output, and ultimate weakening of the left ventricle secondaryto a volume overload and a pressure overload of the left atrium.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

US Patent Application Publication 2007/0055206 to To et al., which isincorporated herein by reference, describes devices, methods, and kitsfor deployment of tissue anchors. In some variations, the devicescomprise a shaft defining a lumen for housing at least one anchortherein (the anchor having an eyelet) and a mechanism for deploying theanchor distally from the lumen, wherein the inner diameter of the lumenis the same size or smaller than the diameter of the eyelet of theanchor to be disposed therein when the anchor is in an expandedconfiguration. In some variations, the methods comprise loading ananchor within a lumen of a shaft (where the anchor comprises an eyeletand the shaft has a slot therethrough), passing a linking member throughthe slot and through the eyelet of the anchor, and deploying the anchor.Other methods comprise loading an anchor within a lumen of a shaft, anddeploying the anchor distally from the lumen.

US Patent Application Publication 2007/0080188 to Spence et al., whichis incorporated herein by reference, describes systems and methods forsecuring tissue including the annulus of a mitral valve. The systems andmethods may employ catheter based techniques and devices to plicatetissue and perform an annuloplasty. Magnets may be used for guidance indeploying fasteners from a catheter. The fasteners are cinched with aflexible tensile member.

U.S. Pat. No. 6,619,291 to Hlavka et al., which is incorporated hereinby reference, describes a minimally invasive method of performingannuloplasty. A method for performing a procedure on a mitral valve of aheart includes inserting an implant into a left ventricle and orientingthe implant in the left ventricle substantially below the mitral valve.The implant and tissue around the mitral valve are connected and tensionis provided to the implant, in one embodiment, in order to substantiallyreduce an arc length associated with the mitral valve. In anotherembodiment, the implant is inserted into the left ventricle through theaorta and the aortic valve.

US Patent Application Publication 2006/0241656 to Starksen et al., whichis incorporated herein by reference, describes devices, systems andmethods for facilitating positioning of a cardiac valve annulustreatment device, thus enhancing treatment of the annulus. Methodsgenerally involve advancing an anchor delivery device throughvasculature of the patient to a location in the heart for treating thevalve annulus, contacting the anchor delivery device with a length ofthe valve annulus, delivering a plurality of coupled anchors from theanchor delivery device to secure the anchors to the annulus, and drawingthe anchors together to circumferentially tighten the valve annulus.Devices generally include an elongate catheter having at least onetensioning member and at least one tensioning actuator for deforming adistal portion of the catheter to help it conform to a valve annulus.The catheter device may be used to navigate a subannular space below amitral valve to facilitate positioning of an anchor delivery device.

US Patent Application Publication 2007/0051377 to Douk et al., which isincorporated herein by reference, describes a catheter-based, annulusreduction device and system for cardiac valve repair and method of usingthe same. The system is usable for treating mitral valve regurgitationand comprises a catheter, a reduction ring carried within the catheter,the reduction ring including a plurality of exit ports formed in a sidewall of the reduction ring and filament received in the reduction ring.The filament includes a plurality of radially extendible barbscorresponding to the sidewall openings. The reduction ring carrying thefilament is deployed adjacent a mitral valve annulus and the filament istranslated relative to the reduction ring to deploy the barbs throughthe exit ports and into the annulus and to further translate thereduction ring with deployed barbs to reshape the annulus.

US Patent Application Publication 2006/0025787 to Morales et al., whichis incorporated herein by reference, describes methods and devices thatprovide constriction of a heart valve annulus to treat cardiac valveregurgitation and other conditions. Embodiments typically include adevice for attaching a cinching or tightening apparatus to a heart valveannulus to reduce the circumference of the annulus, thus reducing valveregurgitation. Tightening devices may include multiple tethered clips,multiple untethered crimping clips, stabilizing devices, visualizationdevices, and the like. In one embodiment, a plurality of tethered clipsis secured circumferentially to a valve annulus, and the tether couplingthe clips is cinched to reduce the circumference of at least a portionof the annulus. Methods and devices may be used in open heart surgicalprocedures, minimally invasive procedures, catheter-based procedures,and/or procedures on beating hearts or stopped hearts.

U.S. Pat. No. 7,431,692 to Zollinger et al., which is incorporatedherein by reference, describes an adjustable support pad for adjustablyholding a tensioning line used to apply tension to a body organ. Theadjustable support pad can include a locking mechanism for preventingslidable movement of the tensioning element in one or both directions.The locking mechanism may include spring-loaded locks, rotatablecam-like structures, and/or rotatable spool structures. The adjustablesupport pad may be formed from rigid, semi-rigid, and/or flexiblematerials, and may be formed to conform to the outer surface of a bodyorgan. The adjustable support pad can be configured to adjustably holdone or more separate tensioning lines, and to provide for independentadjustment of one or more tensioning lines or groups thereof.

US Patent Application Publication 2007/0016287 to Cartledge et al.,which is incorporated herein by reference, describes an implantabledevice for controlling shape and/or size of an anatomical structure orlumen. The implantable device has an adjustable member configured toadjust the dimensions of the implantable device. The implantable deviceis housed in a catheter and insertable from a minimally invasivesurgical entry. An adjustment tool actuates the adjustable member andprovide for adjustment before, during or after the anatomical structureor lumen resumes near normal to normal physiologic function.

US Patent Application Publication 2004/0236419 to Milo, which isincorporated herein by reference, describes methods for reconfiguring anatrioventricular heart valve that may use systems comprising a partialor complete annuloplasty rings proportioned to reconfigure a heart valvethat has become in some way incompetent, a pair of trigonal sutures orimplantable anchors, and a plurality of staples which may have pairs oflegs that are sized and shaped for association with the ring at spacedlocations along its length. These systems permit relative axial movementbetween the staples and the ring, whereby a patient's heart valve can bereconfigured in a manner that does not deter subtle shifting of thenative valve components. Shape-memory alloy material staples may havelegs with free ends that interlock following implantation. Annuloplastyrings may be complete or partial and may be fenestrated. One alternativemethod routes a flexible wire, preferably of shape-memory material,through the bights of pre-implanted staples. Other alternative systemsuse linkers of shape-memory material having hooked ends to interengagewith staples or other implanted supports which, following implantation,decrease in effective length and pull the staples or other supportstoward one another so as to create desired curvature of the reconfiguredvalve. These linkers may be separate from the supports or may beintegral with them and may have a variety of shapes and forms. Variousones of these systems are described as being implanted non-invasivelyusing a delivery catheter.

US Patent Application Publication 2005/0171601 to Cosgrove et al., whichis incorporated herein by reference, describes an annuloplasty repairsegment and template for heart valve annulus repair. The elongateflexible template may form a distal part of a holder that also has aproximal handle. Alternatively, the template may be releasably attachedto a mandrel that slides within a delivery sheath, the template beingreleased from the end of the sheath to enable manipulation by a surgeon.A tether connecting the template and mandrel may also be provided. Thetemplate may be elastic, temperature responsive, or multiple linkedsegments. The template may be aligned with the handle and form a two- orthree-dimensional curve out of alignment with the handle such that theannuloplasty repair segment attached thereto conforms to the curve. Thetemplate may be actively or passively converted between its straight andcurved positions. The combined holder and ring is especially suited forminimally-invasive surgeries in which the combination is delivered to animplantation site through a small access incision with or without acannula, or through a catheter passed though the patient's vasculature.

U.S. Pat. No. 6,296,656 to Bolduc et al. describes a helical fastenerhaving a high retentive surface area. The helical fastener has a firstend for enhancing penetration into tissue and a second end comprising acoil sectioning a diameter of the fastener for receiving longitudinaland rotational forces. The helical fasteners are attached to body tissueby a fastener applicator having a proximal portion comprising a handleand an actuator and an elongate distal portion for housing a pluralityof fasteners. A transferring action of the actuator provideslongitudinal and rotational movement of the fasteners out of the distalportion and into body tissue.

U.S. Pat. No. 7,229,452 to Kayan describes a surgical tack for securinga surgical mesh material to body tissue. The tack includes a pair oflegs and an arcuate cross-member. A surgical tack applier is alsodisclosed, for applying the surgical tack. The applier includes anelongate tubular portion having a jacket with a main channel and a pairof longitudinally extending sub-channels. A rotatable drive rod having ahelical thread is coupled to the applier, and the sub-channels receivethe legs of the tack. The helical thread receives the arcuatecross-member of the surgical tack. Rotation of the drive rod drives thetack from the distal end of the applier.

The following patents and patent application publications, all of whichare incorporated herein by reference, may be of interest:

U.S. Pat. No. 5,306,296 to Wright et al.

U.S. Pat. No. 5,674,279 to Wright et al.

U.S. Pat. No. 5,961,539 to Northrup, III et al.

U.S. Pat. No. 6,524,338 to Gundry

U.S. Pat. No. 6,569,198 to Wilson et al.

U.S. Pat. No. 6,602,288 to Cosgrove et al.

U.S. Pat. No. 6,602,289 to Colvin et al.

U.S. Pat. No. 6,689,164 to Seguin

U.S. Pat. No. 6,702,826 to Liddicoat et al.

U.S. Pat. No. 6,718,985 to Hlavka et al.

U.S. Pat. No. 6,764,510 to Vidlund et al.

U.S. Pat. No. 7,004,176 to Lau

U.S. Pat. No. 7,101,395 to Tremulis et al.

U.S. Pat. No. 7,175,660 to Cartledge et al.

U.S. Pat. No. 7,186,262 to Saadat

U.S. Pat. No. 7,686,822 to Shayani

US Patent Application Publication 2002/0087048 to Brock et al.

US Patent Application Publication 2002/0173841 to Ortiz et al.

US Patent Application Publication 2003/0050693 to Quijano et al.

US Patent Application Publication 2003/0167062 to Gambale et al.

US Patent Application Publication 2004/0024451 to Johnson et al.

US Patent Application Publication 2004/0122514 to Fogarty et al.

US Patent Application Publication 2004/0148021 to Cartledge et al.

US Patent Application Publication 2005/0055087 to Starksen

US Patent Application Publication 2005/0288781 to Moaddeb et al.

US Patent Application Publication 2006/0069429 to Spence et al.

US Patent Application Publication 2007/0162111 to Fukamachi et al.

US Patent Application Publication 2007/0255400 to Parravicini et al.

US Patent Application Publication 2008/0004697 to Lichtenstein et al.

PCT Publication WO 01/26586 to Seguin

PCT Publication WO 02/085251 to Hlavka et al.

PCT Publication WO 02/085252 to Hlavka et al.

PCT Publication WO 06/097931 to Gross et al.

PCT Publication WO 07/136783 to Cartledge et al.

PCT Publication WO 08/068756 to Gross et al.

PCT Publication WO 10/004546 to Gross et al.

The following articles, all of which are incorporated herein byreference, may be of interest:

-   O'Reilly S et al., “Heart valve surgery pushes the envelope,”    Medtech Insight 8(3): 73, 99-108 (2006)-   Dieter R S, “Percutaneous valve repair: Update on mitral    regurgitation and endovascular approaches to the mitral valve,”    Applications in Imaging, Cardiac Interventions, Supported by an    educational grant from Amersham Health pp. 11-14 (2003)-   Swain C P et al., “An endoscopically deliverable tissue-transfixing    device for securing biosensors in the gastrointestinal tract,”    Gastrointestinal Endoscopy 40(6): 730-734 (1994)-   Odell J A et al., “Early Results of a Simplified Method of Mitral    Valve Annuloplasty,” Circulation 92:150-154 (1995)-   Brennan, Jennifer, “510(k) Summary of Safety and Effectiveness,”    January 2008-   Odell J A et al., “Early Results of a Simplified Method of Mitral    Valve Annuloplasty,” Circulation 92:150-154 (1995)

SUMMARY OF THE INVENTION

In some embodiments of the present invention, an adjustable partialannuloplasty ring is provided for repairing a dilated valve annulus ofan atrioventricular valve, such as a mitral valve. The annuloplasty ringcomprises a flexible sleeve and a plurality of anchors. An anchordeployment manipulator is advanced into a lumen of the sleeve, and, fromwithin the lumen, deploys the anchors through a wall of the sleeve andinto cardiac tissue, thereby anchoring the sleeve around a portion ofthe valve annulus. The anchors are typically deployed from a distal endof the manipulator while the distal end is positioned such that acentral longitudinal axis through the distal end of the manipulatorforms an angle with a surface of the cardiac tissue of between about 45and 90 degrees, e.g., between about 75 and 90 degrees, such as about 90degrees. Typically, the anchors are deployed from the distal end of themanipulator into the cardiac tissue in a direction parallel to thecentral longitudinal axis through the distal end of the manipulator.

In some embodiments of the present invention, the anchors are deployedfrom the left atrium into the upper region of the ventricular wall nearthe atrium, tissue of which generally provides more secure anchoringthan does the atrial wall. The above-mentioned angle of deploymentenables such deployment into the upper region of the ventricular wall.

In some embodiments of the present invention, the anchor deploymentmanipulator comprises a steerable outer tube in which is positioned ananchor driver having an elongated, flexible shaft. Rotation of theanchor driver screws the anchors into the cardiac tissue. The anchorsmay, for example, be helical in shape. For some applications, theplurality of anchors are applied using the manipulator by loading afirst one of the anchors onto the anchor driver, and deploying theanchor into the cardiac tissue. The anchor driver is withdrawn from thebody of the subject, and a second one of the anchors is loaded onto theanchor driver. The anchor driver is reintroduced into the sleeve of theannuloplasty ring, and the second anchor is deployed. These steps arerepeated until all of the anchors have been deployed. Alternatively, theanchor driver is configured to simultaneously hold a plurality ofanchors, and to deploy them one at a time.

Typically, the manipulator is gradually withdrawn in a proximaldirection during the anchoring procedure as anchors are deployed. Thefirst anchor is thus deployed most distally in the sleeve (generally ator within a few millimeters of the distal tip of the sleeve), and eachsubsequent anchor is deployed more proximally.

The annuloplasty ring is typically configured to be placed onlypartially around the valve annulus (i.e., to assume a C-shape), and,once anchored in place, to be contracted so as to circumferentiallytighten the valve annulus. To this end, the annuloplasty ring comprisesa flexible contracting member such as a wire, which is typicallypositioned within the lumen of the sleeve. The annuloplasty ring furthercomprises a contracting mechanism which facilitates contracting of theannuloplasty ring. For some applications, the contracting mechanismcomprises a spool to which a first end of the contracting member iscoupled. The spool is positioned in a vicinity of either the proximal orthe distal end of the sleeve. A second end of the contracting member iscoupled to the sleeve in a vicinity of the end of the sleeve oppositethe end to which the spool is positioned. Rotation of the spool winds aportion of the contracting member around the spool, thereby pulling thefar end of the ring toward the spool and tightening the ring. For someapplications, the spool is positioned in a vicinity of the distal end ofthe sleeve, and is oriented such that a driving interface thereof isaccessible from within the sleeve. A screwdriver tool is inserted intothe sleeve, and used to rotate the spool via the driving interface ofthe spool.

All of the tools and elements of the annuloplasty system that areintroduced into left atrium are contained within the sleeve of theannuloplasty ring, which reduces the risk that any elements of thesystem will accidentally be released to the blood circulation, or damagesurrounding tissue. In addition, the lumen of the sleeve providesguidance if it should be necessary to return to a previously deployedanchor, such as to tighten, loosen, remove, or relocate the anchor. Forsome applications, the anchors comprise helical screws, which facilitatesuch adjusting or removing.

The annuloplasty ring may be advanced toward the annulus of a valve inany suitable procedure, e.g., a transcatheter procedure, a minimallyinvasive procedure, or an open heart procedure.

In some embodiments of the present invention, an anchor tissuedeployment system comprises an anchor deployment tool and a plurality oftissue anchors. The anchor deployment tool comprises a flexible outertube, a flexible inner shaft, which is positioned within the flexibleouter tube, and a rotating deployment element, which is coupled to thedistal end of the shaft. The anchor deployment tool is configured toprovide an anchor storage area. The storage area initially stores theplurality of tissue anchors, such that the flexible inner shaft passesthrough channels that pass through each of the anchors, and the anchorsare within the flexible outer tube. The rotating deployment element isconfigured to directly engage the anchors in the anchor storage area oneat a time, advance each of the anchors while engaged in a distaldirection, and deploy each of the anchors through the distal end of theouter tube and into tissue of a subject. Typically, the anchordeployment tool is configured to provide steering functionality to adistal anchor manipulation area of the anchor deployment tool betweenthe anchor storage area and the distal tube end.

For some applications, the anchor deployment tool is configured suchthat, as the rotating deployment element advances each of the anchors inthe distal direction, only the single anchor currently being advanced iswithin the distal anchor manipulation area of the anchor deploymenttool. For some applications, the anchor deployment tool is configured todeploy each of the anchors into the tissue in a direction parallel to acentral longitudinal axis of the outer tube through the distal tube end,and parallel to a central longitudinal axis of the anchor.

For some applications, the rotating deployment element is configured topass through one or more of the anchors without engaging the anchorswhen the rotating deployment element is withdrawn in a proximaldirection within the outer tube, and to directly engage one of theanchors when the rotating deployment element is advanced in the distaldirection against the one of the anchors. Typically, the rotatingdeployment element is configured to assume a radially-compressed statewhen passing through the one or more of the anchors without engaging theanchors, and to assume a radially-expanded state when engaging the oneof the anchors.

For some applications, the anchor deployment tool further comprises ananchor restraining mechanism in a vicinity of the distal anchor storageend. The mechanism is configured to temporarily restrain at least thedistal-most anchor currently stored in the anchor storage area fromadvancing in the distal direction.

For some applications, each of the anchors comprises a helical tissuecoupling element, and a tool-engaging head, fixed to one end of thetissue coupling element. The tool-engaging head is shaped so as todefine an engaging opening that is at least partially non-circular, andthat passes entirely through the tool-engaging head along the axis. Theend of the tissue coupling element is fixed to the tool-engaging headnear an outer perimeter of the tool-engaging head, such that the tissuecoupling element does not block the engaging opening. The tissuecoupling element and the tool-engaging head together define a channelalong an entire length of the tissue anchor, which channel is sized andshaped such that a right circular cylinder could be placed within thechannel, coaxial with the tissue anchor, and along the entire length ofthe tissue anchor. The cylinder typically has a diameter of at least 1mm, such as at least 2 mm.

For some applications, the rotating deployment element is capable ofunscrewing an already-deployed anchor from the tissue, withdrawing theanchor in a proximal direction, and subsequently redeploying the anchorinto the tissue. For some applications, to enable such redeployment, therotating deployment element is configured to selectively assume (a) alocked state, in which the rotating deployment element engages one ofthe anchors, such that the rotating deployment element can withdraw theanchor in the proximal direction, and (b) an unlocked state, in whichthe rotating deployment element does not engage the anchor.

For some applications, the anchor deployment system is used to deployanchors for coupling an annuloplasty ring to tissue of a native cardiacvalve of the subject, such as a mitral valve. For example, theannuloplasty ring may comprise a sleeve having a lumen, and the anchordeployment tool may be configured to be removably positioned within thelumen of the sleeve, and, while so positioned, to deploy the anchorsfrom the distal tube end through a wall of the sleeve into the tissue.Alternatively applications for the anchor deployment system includedelivery anchors via a working channel of an endoscope, such as to mountand secure a support mesh for treating a hernia.

There is therefore provided, in accordance with an embodiment of thepresent invention, apparatus including an annuloplasty system for use ona subject, which includes:

an annuloplasty ring, which includes a sleeve having a lumen;

at least one anchor, shaped so as to define a coupling head and a tissuecoupling element, which tissue coupling element is shaped so as todefine a longitudinal axis, and is configured to penetrate cardiactissue of the subject in a direction parallel to the longitudinal axis;and

an anchor deployment manipulator, configured to be removably positionedwithin the lumen of the sleeve, and, while so positioned, to deploy thetissue coupling element from a distal end of the deployment manipulatorthrough a wall of the sleeve into the cardiac tissue in the directionparallel to the longitudinal axis of the tissue coupling element andparallel to a central longitudinal axis of the deployment manipulatorthrough the distal end of the deployment manipulator.

Typically, the annuloplasty ring includes a partial annuloplasty ring.

For some applications, the coupling element is shaped so as to define ashape selected from the group consisting of: a helix, a spiral, and ascrew shaft.

In an embodiment, the annuloplasty ring includes a spool coupled to thesleeve, and a flexible contracting member that is coupled to the spooland the sleeve, such that winding the contracting member around thespool tightens the ring.

In an embodiment, the deployment manipulator includes steeringfunctionality. For some applications, the deployment manipulatorincludes a tube, which is configured to provide the steeringfunctionality; and an anchor driver, which includes an elongated,flexible shaft which is at least partially positioned within the tube.

In an embodiment, the deployment manipulator is configured to deploy theat least one anchor from the distal end of the deployment manipulatorthrough the wall of the sleeve into the cardiac tissue, while the distalend of the deployment manipulator is positioned such that the centrallongitudinal axis through the distal end of the deployment manipulatorforms an angle of between 45 and 90 degrees with the wall of the sleeveat a point at which the anchor penetrates the wall. For someapplications, the point on the wall is a first point on the wall, andthe angle is a first angle, the at least one anchor is a first anchor ofa plurality of anchors that also includes a second anchor most recentlydeployed before the first anchor through a second point on the wall, andthe deployment manipulator is configured to deploy the first anchorwhile the distal end of the deployment manipulator is positioned suchthat the central longitudinal axis forms a second angle of between 45and 90 degrees with a line defined by the first point and the secondpoint.

For some applications, the apparatus further includes a pusher elementwhich is positioned within the sleeve, and which is configured to, uponbeing pushed distally, move the distal end of the deployment manipulatorproximally within the sleeve by engaging an interior surface of thesleeve.

There is further provided, in accordance with an embodiment of thepresent invention, a method including:

positioning an anchor deployment manipulator at least partially within alumen of a sleeve of an annuloplasty ring;

placing, into an atrium of a subject in a vicinity of an annulus of anatrioventricular valve, at least a portion of the sleeve that contains adistal end of the deployment manipulator; and

deploying at least one anchor from the distal end of the deploymentmanipulator through a wall of the sleeve such that a coupling element ofthe anchor enters cardiac tissue of the subject in a direction parallelto a central longitudinal axis of the deployment manipulator through thedistal end of the deployment manipulator.

In an embodiment, deploying includes deploying the at least one anchorfrom the distal end of the deployment manipulator through the wall ofthe sleeve into the cardiac tissue, while the distal end of thedeployment manipulator is positioned such that the central longitudinalaxis of the deployment manipulator through the distal end of thedeployment manipulator forms an angle of between 45 and 90 degrees withthe wall of the sleeve at a point at which the anchor penetrates thewall. For some applications, the point on the wall is a first point onthe wall, and the angle is a first angle, the at least one anchor is afirst anchor of a plurality of anchors that also includes a secondanchor most recently deployed before the first anchor through a secondpoint on the wall, and deploying the first anchor includes deploying thefirst anchor while the distal end of the deployment manipulator ispositioned such that the central longitudinal axis forms a second angleof between 45 and 90 degrees with a line defined by the first point andthe second point.

Typically, the annuloplasty ring includes a partial annuloplasty ring,and positioning the deployment manipulator includes positioning thedeployment manipulator within the lumen of the partial annuloplastyring.

In an embodiment, the deployment manipulator includes steeringfunctionality, and placing the sleeve includes steering the deploymentmanipulator using the steering functionality.

For some applications, deploying the anchor includes deploying theanchor from the atrium into an upper region of a ventricular wall nearthe atrium.

For some applications, the method further includes positioning a pusherelement at least partially within the lumen of the sleeve of theannuloplasty ring; and moving the distal end of the deploymentmanipulator proximally within the sleeve by pushing the pusher elementdistally such that the pusher element engages an interior surface of thesleeve.

In an embodiment, the method further includes tightening theannuloplasty ring by winding a flexible contracting member of the ringaround a spool coupled to the ring.

There is still further provided, in accordance with an embodiment of thepresent invention, apparatus including an annuloplasty system for use ona subject, which includes:

an annuloplasty ring, which includes a sleeve having a lumen;

at least one anchor; and

an anchor deployment manipulator, configured to be removably positionedwithin the lumen of the sleeve, and, while so positioned, to deploy theat least one anchor from a distal end of the deployment manipulatorthrough a wall of the sleeve into cardiac tissue of the subject, whilethe distal end of the deployment manipulator is positioned such that acentral longitudinal axis of the deployment manipulator through thedistal end of the deployment manipulator forms an angle of between 45and 90 degrees with the wall of the sleeve at a point at which theanchor penetrates the wall.

Typically, the annuloplasty ring includes a partial annuloplasty ring.

In an embodiment, the deployment manipulator includes steeringfunctionality.

For some applications, the point on the wall is a first point on thewall, and the angle is a first angle, the at least one anchor is a firstanchor of a plurality of anchors that also includes a second anchor mostrecently deployed before the first anchor through a second point on thewall, and the anchor deployment manipulator is configured to deploy thefirst anchor while the distal end of the deployment manipulator ispositioned such that the central longitudinal axis forms a second angleof between 45 and 90 degrees with a line defined by the first point andthe second point.

For some applications, the anchor is shaped so as to define a couplinghead and a tissue coupling element, which tissue coupling element isshaped so as to define a longitudinal axis, and is configured topenetrate cardiac tissue of the subject in a direction parallel to thelongitudinal axis, and the anchor deployment manipulator is configuredto deploy the anchor from the distal end of the deployment manipulatorsuch that the coupling element enters the cardiac tissue in a directionparallel to the central longitudinal axis of the deployment manipulatorthrough the distal end of the deployment manipulator.

For some applications, the anchor is shaped so as to define a couplinghead and a tissue coupling element, which is shaped so as to define ashape selected from the group consisting of: a helix, a spiral, and ascrew shaft.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method including:

positioning an anchor deployment manipulator at least partially within alumen of a sleeve of an annuloplasty ring;

placing, into an atrium of a subject in a vicinity of an annulus of anatrioventricular valve, at least a portion of the sleeve that contains adistal end of the deployment manipulator; and

deploying at least one anchor from the distal end of the deploymentmanipulator through a wall of the sleeve into cardiac tissue of thesubject, while the distal end of the deployment manipulator ispositioned such that a central longitudinal axis of the deploymentmanipulator through the distal end of the deployment manipulator formsan angle of between 45 and 90 degrees with the wall of the sleeve at apoint at which the anchor penetrates the wall.

For some applications, deploying includes deploying the at least oneanchor while the angle is between 75 and 90 degrees.

In an embodiment, the deployment manipulator includes steeringfunctionality, and placing the sleeve includes steering the deploymentmanipulator using the steering functionality.

Typically, the annuloplasty ring includes a partial annuloplasty ring,and positioning the anchor deployment manipulator includes positioningthe anchor deployment manipulator at least partially within the lumen ofthe partial annuloplasty ring.

For some applications, the point on the wall is a first point on thewall, and the angle is a first angle, the at least one anchor is a firstanchor of a plurality of anchors that also includes a second anchor mostrecently deployed before the first anchor through a second point on thewall, and deploying the first anchor includes deploying the first anchorwhile the distal end of the deployment manipulator is positioned suchthat the central longitudinal axis forms a second angle of between 45and 90 degrees with a line defined by the first point and the secondpoint.

For some applications, deploying the anchor includes deploying theanchor from the distal end of the deployment manipulator such that acoupling element of the anchor enters the cardiac tissue in a directionparallel to the central longitudinal axis.

For some applications, the anchor is shaped so as to define a couplinghead and a tissue coupling element, which is shaped so as to define ashape selected from the group consisting of: a helix, a spiral, and ascrew shaft, and deploying the anchor includes screwing the tissuecoupling element into the cardiac tissue.

In an embodiment, the method further includes tightening theannuloplasty ring by winding a flexible contracting member of the ringaround a spool coupled to the ring.

For some applications, deploying the anchor includes deploying theanchor from the atrium into an upper region of a ventricular wall nearthe atrium.

For some applications, the deployment manipulator includes an anchordriver positioned within a sheath, the at least one anchor includes aplurality of anchors, and deploying the at least one anchor includes:

-   -   loading a first one of the anchors onto the anchor driver;    -   deploying the first one of the anchors through a wall of the        sleeve and into the cardiac tissue;    -   withdrawing the anchor driver from the sheath and a body of the        subject, while leaving the sheath lumen of the sleeve;    -   subsequently loading a second one of the anchors onto the anchor        driver while the anchor driver is outside the body;    -   subsequently reintroducing the anchor driver into the body and        the sheath; and    -   subsequently deploying the second one of the anchors through the        wall of the sleeve into the cardiac tissue.

For some applications, placing the at least a portion of the sleeveincludes placing the at least a portion of the sleeve into a rightatrium of the subject in a vicinity of a tricuspid valve. Alternatively,placing the at least a portion of the sleeve includes placing the atleast a portion of the sleeve into a left atrium of the subject in avicinity of the annulus of a mitral valve.

There is yet additionally provided, in accordance with an embodiment ofthe present invention, a method including:

positioning, during a transcatheter procedure, an anchor deploymentmanipulator at least partially in an atrium of a subject;

placing, into the atrium in a vicinity of an annulus of anatrioventricular valve, at least a portion of an annuloplasty ring; and

coupling the annuloplasty ring to cardiac tissue by deploying at leastone anchor from the deployment manipulator in the atrium and into anupper region of a ventricular wall near the atrium.

Typically, the atrioventricular valve is selected from the groupconsisting of: a mitral valve and a tricuspid valve.

In an embodiment, positioning the anchor deployment manipulator includespositioning at least a distal end of the deployment manipulator within alumen of a sleeve of the annuloplasty ring, and coupling includescoupling the ring to the cardiac tissue by deploying the at least oneanchor from the distal end of the deployment manipulator in the atrium,through a wall of the sleeve, and into the upper region of theventricular wall. For some applications, deploying the anchor includesdeploying the anchor into the upper region of the ventricular wall whilethe distal end of the deployment manipulator is positioned such that acentral longitudinal axis of the deployment manipulator through thedistal end of the deployment manipulator forms an angle of between 45and 90 degrees with the wall of the sleeve at a point at which theanchor penetrates the wall.

For some applications, deploying the anchor includes deploying theanchor from the distal end of the deployment manipulator into the upperregion of ventricular wall such that a coupling element of the anchorenters the ventricular wall in a direction parallel to a centrallongitudinal axis of the deployment manipulator through the distal endof the deployment manipulator.

There is also provided, in accordance with an embodiment of the presentinvention, apparatus including an annuloplasty system for use on asubject, the system including:

an annuloplasty ring, which includes a sleeve having a lumen;

at least one anchor;

an anchor deployment manipulator, which is configured to be removablypositioned within the lumen of the sleeve, and which is configure todeploy the at least one anchor through a wall of the sleeve into cardiactissue of the subject; and

a pusher element which is positioned within the sleeve, and which isconfigured to, upon being pushed distally, move the distal end of thedeployment manipulator proximally within the sleeve by engaging aninterior surface of the sleeve.

In an embodiment, the deployment manipulator includes an outer tube thatis shaped so as to define an opening that is within 3 mm of a distal endof the tube; and an anchor driver that is positioned at least partiallywithin the outer tube, and which is configured to deploy the at leastone anchor, and the pusher element is positioned such that a proximalportion thereof is within the outer tube, and a distal portion thereofextends out of the tube through the opening and into the lumen of thesleeve.

In an embodiment, the deployment manipulator includes an outer tube; andan anchor driver that is positioned at least partially within the outertube, and which is configured to deploy the at least one anchor, and thepusher element is positioned outside of the outer tube.

For some applications, the pusher element is configured to, upon beingpushed distally, move the distal end of the deployment manipulatorproximally within the sleeve by engaging a distal end of the sleeve.Alternatively or additionally, the pusher element is configured to, uponbeing pushed distally, move the distal end of the deployment manipulatorproximally within the sleeve by engaging the wall of the sleeve.

Typically, the annuloplasty ring includes a partial annuloplasty ring.

In an embodiment, the annuloplasty ring includes a spool coupled to thesleeve, and a flexible contracting member that is coupled to the spooland the sleeve, such that winding the contracting member around thespool tightens the ring.

There is further provided, in accordance with an embodiment of thepresent invention, a method including:

positioning an anchor deployment manipulator and a pusher element atleast partially within a lumen of a sleeve of an annuloplasty ring;

placing, into an atrium of a subject in a vicinity of an annulus of anatrioventricular valve, at least a portion of the sleeve that contains adistal end of the deployment manipulator and a distal end of the pusherelement;

moving the distal end of the deployment manipulator proximally withinthe sleeve by pushing the pusher element distally such that the pusherelement engages an interior surface of the sleeve; and

after moving the distal end of the deployment manipulator, deploying ananchor from the distal end of the deployment manipulator through a wallof the sleeve into cardiac tissue.

For some applications, the deployment manipulator includes an outer tubethat is shaped so as to define an opening that is within 3 mm of adistal end of the tube, and positioning the pusher element at leastpartially within the lumen of the sleeve includes positioning the pusherelement such that (a) a distal portion of the pusher element extends outof the tube through the opening and into the lumen of the sleeve, and(b) a proximal portion of the pusher element passes through the tubefrom the opening to a proximal end of the tube.

For some applications, the deployment manipulator includes an outertube, and positioning the pusher element at least partially within thelumen of the sleeve includes positioning the pusher element outside ofthe outer tube.

For some applications, moving includes moving the distal end of thedeployment manipulator by pushing the pusher element distally such thatthe pusher element engages a distal end of the sleeve. Alternatively oradditionally, moving includes moving the distal end of the deploymentmanipulator by pushing the pusher element distally such that the pusherelement engages the wall of the sleeve.

For some applications, moving the distal end of the deploymentmanipulator includes moving the distal end of the deployment manipulatora certain distance by pushing the pusher element the certain distance.

There is still further provided, in accordance with an embodiment of thepresent invention, apparatus including an annuloplasty ring for use on asubject, which includes:

a sleeve shaped so as to define a lumen therein that is open at aproximal end of the sleeve;

a contracting mechanism, coupled to the sleeve in a vicinity of a distalend of the sleeve; and

an elongated contracting member, a first end of which is coupled to thecontracting mechanism, and a second end of which is coupled to thesleeve in a vicinity of the proximal end of the sleeve,

wherein the contracting mechanism includes a driving interface that ispositioned so as to be accessible from within the lumen of the sleeve,and

wherein the contracting mechanism is configured such that rotation ofthe driving interface shortens the ring by tightening the elongatedcontracting member.

Typically, the annuloplasty ring includes a partial annuloplasty ring.

For some applications, the apparatus further includes a screwdrivertool, which includes a head and a shaft, and the screwdriver tool isconfigured to be removably inserted partially into the lumen of thesleeve via the proximal end of the sleeve, such that the head isremovably coupled from within the lumen to the driving interface of thecontracting mechanism.

In an embodiment, the apparatus further includes at least one anchor;and an anchor deployment manipulator, configured to be removablypositioned within the lumen of the sleeve, and, while so positioned, todeploy the anchor from a distal end of the deployment manipulatorthrough a wall of the sleeve into cardiac tissue of the subject.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method including:

coupling a sleeve of an annuloplasty ring to cardiac tissue of a subjectat a plurality of sites in a vicinity of an annulus of anatrioventricular valve;

partially inserting a screwdriver tool into a lumen of the sleeve, thetool having a head and a shaft; and

rotating the screwdriver tool such that the head, while within the lumenof the sleeve, shortens the ring by rotating a contracting mechanism ofthe ring that tightens an elongated contracting member coupled to thesleeve.

Typically, the annuloplasty ring includes a partial annuloplasty ring,and coupling includes coupling the sleeve of the partial annuloplastyring to the cardiac tissue.

There is further provided, in accordance with an application of thepresent invention, apparatus including:

a plurality of tissue anchors, which are shaped so as to definerespective channels along entire longitudinal lengths of the anchors;and

an anchor deployment tool, which includes:

-   -   a flexible outer tube, which has a distal tube end;    -   a flexible inner shaft, which is positioned within the flexible        outer tube, and has a distal shaft end; and    -   a rotating deployment element, which is coupled to the distal        shaft end,

wherein the anchor deployment tool is configured to provide an anchorstorage area, which is configured to initially store the plurality oftissue anchors, such that the flexible inner shaft passes through thechannels of the anchors, and the anchors are within the flexible outertube, and

wherein the rotating deployment element is configured to directly engagethe anchors in the anchor storage area one at a time, advance each ofthe anchors while engaged in a distal direction, and deploy each of theanchors through the distal tube end and into tissue of a subject.

Typically, the anchor deployment tool is configured such that, as therotating deployment element advances each of the anchors in the distaldirection, only the single anchor currently being advanced is within adistal anchor manipulation area of the anchor deployment tool betweenthe distal anchor storage area end and the distal tube end.

For some applications, the anchor deployment tool is configured todeploy each of the anchors into the tissue in a direction parallel to acentral longitudinal axis of the outer tube through the distal tube end,and parallel to a central longitudinal axis of the anchor.

For some applications, the anchor storage area has a distal anchorstorage end at a distance of between 1 and 90 cm from the distal tubeend, such as between 5 and 25 cm.

For some applications, the anchor deployment tool is configured toprovide steering functionality to a distal anchor manipulation area ofthe anchor deployment tool between the distal anchor storage area endand the distal tube end. For some applications, the flexible outer tubeis configured to provide the steering functionality to the distal anchormanipulation area. Alternatively or additionally, the flexible innershaft is configured to provide the steering functionality to the distalanchor manipulation area.

For some applications, the rotating deployment element is configured topass through one or more of the anchors without engaging the anchorswhen the rotating deployment element is withdrawn in a proximaldirection within the outer tube, and to directly engage one of theanchors when the rotating deployment element is advanced in the distaldirection against the one of the anchors. Typically, the rotatingdeployment element is configured to assume a radially-compressed statewhen passing through the one or more of the anchors without engaging theanchors, and to assume a radially-expanded state when engaging the oneof the anchors.

For some applications, the anchor deployment tool further includes aspring, which is arranged to apply a distally-directed force to aproximal-most one of the anchors stored within the anchor storage area,which force advances the anchors remaining in the anchor storage area inthe distal direction, when the rotating deployment element advances adistal-most one of the anchors out of the anchor storage area in thedistal direction. Alternatively, for some applications, the anchorstorage area is configured to provide a plurality of anchor storagelocations, the anchors are initially stored in respective ones of atleast a portion of the anchor storage locations, and when the rotatingdeployment element advances a distal-most one of the anchors out of theanchor storage area in the distal direction, the anchors remaining inthe anchor storage area remain in their respective initial anchorstorage locations.

For some applications, the plurality of anchors includes at least 6anchors.

For some applications, the anchor deployment tool further includes ananchor restraining mechanism in a vicinity of a distal end of the anchorstorage area, which mechanism is configured to temporarily restrain atleast a distal-most one of the anchors currently stored in the anchorstorage area from advancing in the distal direction.

For some applications, each of the anchors has a central longitudinalaxis, and includes:

a helical tissue coupling element, having proximal and distal ends; and

a tool-engaging head, fixed to the proximal end of the tissue couplingelement, which tool-engaging head is shaped so as to define anon-circular engaging opening that passes entirely through thetool-engaging head along the axis,

wherein the tissue coupling element and the tool-engaging head togetherdefine the channel of the tissue anchor along an entire length of thetissue anchor, which channel is sized and shaped such that a rightcircular cylinder could be placed within the channel, coaxial with thetissue anchor, and along the entire length of the tissue anchor, and

wherein the rotating coupling element is configured to removably engagethe tool-engaging head.

For some applications, the cylinder has a diameter of at least 1 mm,such as at least 2 mm.

For some applications, the apparatus further includes an annuloplastyring, which includes a sleeve having a lumen, and the anchor deploymenttool is configured to be removably positioned within the lumen of thesleeve, and, while so positioned, to deploy the anchors from the distaltube end through a wall of the sleeve into the tissue.

For some applications, the distance between the distal anchor storageend and the distal tube end is between 5 and 25 cm.

For some applications, the anchor deployment tool further includes ahemostasis valve, which includes a distal port to which a proximal endof the flexible outer tube is sealingly coupled. The flexible innershaft passes through the valve, which maintains a seal around the innershaft, while allowing the inner shaft to slide distally and proximallythrough the valve.

For some applications, the rotating deployment element is capable ofunscrewing an already-deployed one of the anchors from the tissue,withdrawing the anchor in a proximal direction, and subsequentlyredeploying the anchor into the tissue.

For some applications, the rotating deployment element includes alocking mechanism that is configured to selectively assume (a) a lockedstate, in which the locking mechanism, even upon withdrawal of therotating deployment element in a proximal direction, preventsdisengagement of the rotating deployment element from one of the anchorswhich the rotating deployment element engages, and (b) an unlockedstate, in which the locking mechanism does not prevent disengagement ofthe rotating deployment element from the anchor upon the withdrawal ofthe rotating deployment element in the proximal direction.

There is further provided, in accordance with an application of thepresent invention, apparatus including a tissue anchor, which has acentral longitudinal axis, and which includes:

a helical tissue coupling element, having proximal and distal ends; and

a tool-engaging head, fixed to the proximal end of the tissue couplingelement, which tool-engaging head is shaped so as to define anon-circular engaging opening that passes entirely through thetool-engaging head along the axis,

wherein the tissue coupling element and the tool-engaging head togetherdefine a channel along an entire length of the tissue anchor, whichchannel is sized and shaped such that a right circular cylinder could beplaced within the channel, coaxial with the tissue anchor, and along theentire length of the tissue anchor.

For some applications, the cylinder has a diameter of at least 1 mm,such as at least 2 mm.

For some applications, the proximal end of the tissue coupling elementis fixed to the tool-engaging head near an outer perimeter of thetool-engaging head, such that the tissue coupling element does not blockthe engaging opening. For some applications, a distance between (a) acenter of the proximal end of the tissue coupling element and (b) theouter perimeter of the tool-engaging head is no more than 30% of a widthof the tool-engaging head.

For some applications, a portion of the helical tissue coupling element,at the proximal end which is fixed to the tool-engaging head, isgenerally straight and oriented at angle of between 0 and 15 degreeswith the central longitudinal axis.

There is still further provided, in accordance with an application ofthe present invention, apparatus including:

a plurality of tissue anchors; and

an anchor deployment tool, which (a) is configured to provide an anchorstorage area that is configured to initially store the plurality oftissue anchors, and (b) includes a rotating deployment element, whichis:

-   -   configured to directly engage the anchors in the anchor storage        area one at a time, advance each of the anchors while engaged in        a distal direction, and deploy each of the anchors through the        distal tube end and into tissue of a subject by screwing the        anchor into the tissue, and    -   capable of unscrewing an already-deployed one of the anchors        from the tissue, withdrawing the anchor in a proximal direction,        and subsequently redeploying the anchor into the tissue.

For some applications, the rotating deployment element includes alocking mechanism that is configured to selectively assume (a) a lockedstate, in which the locking mechanism, even upon withdrawal of therotating deployment element in the proximal direction, preventsdisengagement of the rotating deployment element from one of the anchorswhich the rotating deployment element engages, and (b) an unlockedstate, in which the locking mechanism does not prevent disengagement ofthe rotating deployment element from the anchor upon the withdrawal ofthe rotating deployment element in the proximal direction.

There is additionally provided, in accordance with an application of thepresent invention, a method including:

providing an anchor deployment tool, which includes a flexible outertube, a flexible inner shaft, which is positioned within the flexibleouter tube, and a rotating deployment element, which is coupled to adistal shaft end of the flexible inner shaft;

providing a plurality of tissue anchors, which are shaped so as todefine respective channels along entire longitudinal lengths of theanchors, and which are initially stored within an anchor storage areaprovided by the anchor deployment tool, such that the flexible innershaft passes through the channels of the anchors, and the anchors arewithin the flexible outer tube; and

using the rotating deployment element, directly engaging the anchors inthe anchor storage area one at a time, advancing each of the anchorswhile engaged in a distal direction, and deploying each of the anchorsthrough the distal tube end and into tissue of a subject.

For some applications, advancing each of the anchors includes advancingeach of the anchors in the distal direction such that only the singleanchor currently being advanced is within a distal anchor manipulationarea of the anchor deployment tool between the distal anchor storagearea end and the distal tube end.

For some applications, deploying includes deploying each of the anchorsinto the tissue in a direction parallel to a central longitudinal axisof the outer tube through the distal tube end, and parallel to a centrallongitudinal axis of the anchor.

For some applications, deploying includes steering a distal anchormanipulation area of the anchor deployment tool between the distalanchor storage area end and the distal tube end.

For some applications, directly engaging, advancing, and deploying theanchors includes directly engaging, advancing, and deploying a first oneof the anchors into the tissue at a first site; and, thereafter,directly engaging, advancing, and deploying a second one of the anchorsinto the tissue at a second site, different from the first site. Forsome applications, directly engaging the second anchor includeswithdrawing the rotating deployment element in a proximal directionwithin the outer tube, such that the rotating deployment element passesthrough one or more of the anchors without engaging the anchors; anddirectly engaging the second anchor by advancing the rotating deploymentelement in the distal direction against the second anchor. For someapplications, withdrawing includes withdrawing the rotating deploymentelement such that the rotating deployment element assumes aradially-compressed state when passing through the one or more of theanchors without engaging the anchors, and engaging includes engaging thesecond anchor when the rotating deployment element assumes aradially-expanded state.

For some applications, providing the plurality of anchors includesproviding at least 6 anchors.

For some applications, deploying includes deploying each of the anchorsinto cardiac tissue of the subject. For some applications, deployingincludes removably positioning the anchor deployment tool within a lumenof a sleeve of an annuloplasty ring, and, while so positioned, todeploying the anchors from the distal tube end through a wall of thesleeve into the tissue.

For some applications, providing the anchor deployment tool includesproviding the anchor deployment tool in which the anchor storage areahas a distal anchor storage end at a distance of between 1 and 90 cmfrom the distal tube end, such as between 5 and 25 cm.

For some applications, the method further includes, using the rotatingdeployment element, unscrewing an already-deployed one of the anchorsfrom the tissue, withdrawing the anchor in a proximal direction, andsubsequently redeploying the anchor into the tissue. For someapplications, the rotating deployment element includes a lockingmechanism that is configured to selectively assume a locked state, inwhich the locking mechanism, even upon withdrawal of the rotatingdeployment element in the proximal direction, prevents disengagement ofthe rotating deployment element from the anchor, the method furtherincludes causing the locking mechanism to assume the locked state, andwithdrawing the anchor includes withdrawing the anchor in the proximaldirection while the rotating deployment element is in the locked state.

There is yet additionally provided, in accordance with an application ofthe present invention, a method including:

providing a tissue anchor having proximal and distal ends, which has acentral longitudinal axis, and which includes a helical tissue couplingelement, and a tool engaging head, fixed to the proximal end of thetissue coupling element, which tool-engaging head is shaped so as todefine a non-circular engaging opening that passes entirely through thetool-engaging head along the axis, wherein the tissue coupling elementand the tool-engaging head together define a channel along an entirelength of the tissue anchor, which channel is sized and shaped such thata right circular cylinder could be placed within the channel, coaxialwith the tissue anchor, and along the entire length of the tissueanchor; and

coupling the tissue anchor to tissue of a subject, by rotating thetissue coupling element into the tissue.

For some applications, a distance between (a) a center of the proximalend of the tissue coupling element and (b) the outer perimeter of thetool-engaging head is no more than 30% of a width of the tool-engaginghead, and coupling includes coupling a sheet to the tissue using thetissue anchor, sensing increased resistance to rotation of the tissuecoupling element when the sheet resists the rotation, and, responsivelythe sensed increased resistance, ceasing rotating the tissue couplingelement into the tissue.

There is also provided, in accordance with an application of the presentinvention, a method including:

providing a plurality of tissue anchors;

providing an anchor deployment tool, which (a) is configured to providean anchor storage area, which is configured to initially store theplurality of tissue anchors, and (b) includes a rotating deploymentelement;

using the rotating deployment element, directly engaging the anchors inthe anchor storage area one at a time, advancing each of the anchorswhile engaged in a distal direction, and deploying each of the anchorsthrough the distal tube end and into tissue of a subject by screwing theanchor into the tissue; and

subsequently, using the rotating deployment element, unscrewing analready-deployed one of the anchors from the tissue, withdrawing theanchor in a proximal direction, and subsequently redeploying the anchorinto the tissue.

For some applications, the rotating deployment element includes alocking mechanism that is configured to selectively to assume a lockedstate, in which the locking mechanism, even upon withdrawal of therotating deployment element in the proximal direction, preventsdisengagement of the rotating deployment element from the anchor, themethod further includes causing the locking mechanism to assume thelocked state, and withdrawing the anchor includes withdrawing the anchorin the proximal direction while the rotating deployment element is inthe locked state.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are schematic illustrations of an adjustable partialannuloplasty ring in a non-contracted state, in accordance withrespective embodiments of the present invention;

FIG. 2 is a schematic longitudinal cross-sectional illustration of ananchor deployment manipulator, in accordance with an embodiment of thepresent invention;

FIG. 3 is a schematic longitudinal cross-sectional illustration of theanchor deployment manipulator of FIG. 2 advanced into the annuloplastyring of FIG. 1A, in accordance with an embodiment of the presentinvention;

FIG. 4 is a schematic cross-sectional illustration of the anchordeployment manipulator of FIG. 2 advanced into the annuloplasty ring ofFIG. 1A or 1B, taken along section IV-IV of FIG. 3, in accordance withan embodiment of the present invention;

FIGS. 5A-B are schematic illustrations of a screwdriver tool being usedto rotate a spool of a contracting mechanism of the rings of FIGS. 1Aand 1B, respective, in accordance with respective embodiments of thepresent invention;

FIGS. 6A-I are schematic illustrations of a procedure for implanting theannuloplasty ring of FIG. 1A to repair a mitral valve, in accordancewith an embodiment of the present invention;

FIG. 7 is a schematic illustration of the deployment of an anchor intocardiac tissue, in accordance with an embodiment of the presentinvention;

FIG. 8 is a schematic illustration of the system of FIGS. 1-4 comprisinga flexible pusher element, in accordance with an embodiment of thepresent invention;

FIG. 9 is a schematic illustration of a pusher tube applied to aproximal end of the sleeve of FIGS. 1-4, in accordance with anembodiment of the present invention;

FIGS. 10 and 11 are schematic illustrations of the system of FIGS. 1-4comprising a steerable tube, in accordance with respective embodimentsof the present invention;

FIG. 12 is a schematic illustration of the system of FIGS. 1-4comprising a pulling wire, in accordance with an embodiment of thepresent invention;

FIGS. 13A-B are schematic illustrations of an anchor deployment system,in accordance with an application of the present invention;

FIGS. 14 and 15A-B are schematic illustrations showing the assembly ofcomponents of the anchor deployment system of FIGS. 13A-B, in accordancewith an application of the present invention;

FIGS. 16A-D are schematic illustrations of the deployment of a singleanchor into tissue using an anchor deployment tool of the anchordeployment system of FIGS. 13A-B, in accordance with an application ofthe present invention;

FIGS. 17A-B are schematic illustrations of an alternative configurationof the anchor deployment system of FIGS. 13A-B, in accordance with anapplication of the present invention;

FIGS. 18A-C are schematic illustrations of an anchor of the anchordeployment system of FIGS. 13A-B from three different views, inaccordance with an application of the present invention;

FIGS. 19A and 19B are schematic illustrations of a rotating deploymentelement of the anchor deployment system of FIGS. 13A-B inradially-expanded and radially-compressed states, respectively, inaccordance with an application of the present invention;

FIGS. 20A and 20B are schematic illustrations of the rotating deploymentelement of FIGS. 19A-B engaging a tool-engaging head of the anchor ofFIGS. 18A-C, with the element in locked and unlocked states,respectively, in accordance with an application of the presentinvention; and

FIGS. 21A-I are schematic illustrations of a procedure for implanting anannuloplasty ring to repair a mitral valve, in accordance with anapplication of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

FIGS. 1-4 are schematic illustrations of a system 20 for repairing adilated atrioventricular valve, such as a mitral valve, in accordancewith an embodiment of the present invention. System 20 comprises anadjustable partial annuloplasty ring 22, shown alone in FIGS. 1A and 1Bin a non-contracted state, and an anchor deployment manipulator 24,shown alone in FIG. 2. Annuloplasty ring 22 comprises a flexible sleeve26. Anchor deployment manipulator 24 is advanced into sleeve 26, asshown in FIGS. 3 and 4, and, from within the sleeve, deploys anchors 38through a wall of the sleeve into cardiac tissue, thereby anchoring thering around a portion of the valve annulus.

FIGS. 1A and 1B are schematic illustration of annuloplasty ring 22 in anon-contracted state, in accordance with respective embodiments of thepresent invention. Sleeve 26 is typically configured to be placed onlypartially around the valve annulus (i.e., to assume a C-shape), and,once anchored in place, to be contracted so as to circumferentiallytighten the valve annulus. Alternatively, the ring is configured to beplaced entirely around the valve annulus. In order to tighten theannulus, annuloplasty ring 22 comprises a flexible elongated contractingmember 30 that extends along the ring.

Annuloplasty ring 22 further comprises a contracting mechanism 40, whichfacilitates contracting of the annuloplasty ring. Contracting mechanism40 is described in more detail hereinbelow. In addition, the ringcomprises a plurality of anchors 38, typically between about 5 and about20 anchors, such as about 10 or about 16 anchors. In FIGS. 1A and 1B,anchors 38 are shown prior to their insertion into ring 22, while inFIG. 3 one of the anchors is shown deployed through the wall of sleeve26, and a second one of the anchors is shown during deployment by anchordeployment manipulator 24. The insertion of the anchors into the sleeveand deployment of the anchors into cardiac tissue is described in detailhereinbelow.

Flexible sleeve 26 may comprise a braided, knitted, or woven mesh or atubular structure comprising ePTFE. For some applications, the braidcomprises metal and fabric fibers. The metal fibers, which may compriseNitinol for example, may help define the shape of the sleeve, e.g., holdthe sleeve open to provide space for passage and manipulation ofdeployment manipulator 24 within the sleeve. The fabric fibers maypromote tissue growth into the braid. Optionally, the sleeve is somewhatelastic, which gives the sleeve a tendency to longitudinally contract,thereby helping tighten the sleeve. For example, the sleeve may bebellows- or accordion-shaped.

Typically, the sleeve is configured to have a tendency to assume astraight shape. This straightness helps the surgeon locate the next sitefor each subsequent anchor during the implantation procedure, asdescribed hereinbelow with reference to FIGS. 6A-I. For example, becausethe sleeve assumes a generally straight shape, the sleeve may helpprovide an indication of distance between adjacent anchoring sites.

For some applications, the sleeve is configured to have a controllablyvariable stiffness. For example, a somewhat stiff wire may be placed inthe sleeve to provide the stiffness, and subsequently be removed at theconclusion of the implantation procedure when the stiffness is no longeruseful.

Elongated contracting member 30 comprises a wire, a ribbon, a rope, or aband, which typically comprises a flexible and/or superelastic material,e.g., nitinol, polyester, stainless steel, or cobalt chrome. In someembodiments, contracting member 30 comprises a braided polyester suture(e.g., Ticron). In some embodiments, contracting member 30 is coatedwith polytetrafluoroethylene (PTFE). In some embodiments, contractingmember 30 comprises a plurality of wires that are intertwined to form arope structure.

For some applications, contracting member 30 is positioned at leastpartially within a lumen of the sleeve 26, such as entirely within thelumen (as shown in FIGS. 1A-B, 5A-B, 6H, and 6I). For some applicationsin which the contracting member is positioned partially within thelumen, the contracting member is sewn into the wall of the sleeve, suchthat the contracting member is alternatingly inside and outside of thesleeve along the length of the sleeve (as shown in FIGS. 3, 8, and 9).Optionally, sleeve 26 defines an internal channel within which member 30is positioned (configuration not shown). Alternatively, the contractingmember is disposed outside the lumen of the sleeve, such as alongside anouter wall of the sleeve. For example, sleeve 26 may define an externalchannel within which member 30 is positioned, or the sleeve may compriseor be shaped so as to define external coupling elements, such as loopsor rings (configuration not shown). For some applications, contractingmember 30 is positioned approximately opposite the anchors.

In an embodiment of the present invention, contracting mechanism 40comprises a housing 44 which houses a spool 46, i.e., a rotatablestructure, to which a first end 47 of contracting member 30 is coupled.Spool 46 is positioned in a vicinity of (e.g., within 1 cm of) either adistal end 51 of sleeve 26, as shown in FIGS. 1A and 3, or a proximalend 49 of sleeve 26, as shown in FIG. 1B. A second end 53 of contractingmember 30 is coupled to the sleeve in a vicinity of (e.g., within 1 cmof) the end of the sleeve opposite the end to which the spool ispositioned. In the configuration shown in FIGS. 1A and 3, second end 53of contracting member 30 is coupled to the sleeve in a vicinity ofproximal end 49 of the sleeve, while in the configuration shown in FIG.1B, the second end of the contracting member is coupled to the sleeve ina vicinity of distal end 51 of the sleeve. Rotation of spool 46 winds aportion of the contracting member around the spool, thereby pulling thefar end of the ring toward the spool and shortening and tightening thering.

Alternatively, in some configurations, spool 46 is positioned at anintermediary position along the sleeve, rather than in a vicinity of oneof the ends. For these configurations, contracting member 30 comprisestwo contracting members, which are respectively connected to the twoends of the sleeve, and both of which are connected to the spool.Rotating the spool contracts both contracting members. Theseconfigurations may be implemented using techniques described in U.S.patent application Ser. No. 12/341,960 to Cabiri, which published as USPatent Application Publication 2010/0161047 and is incorporated hereinby reference, with reference to FIG. 15 thereof.

Spool 46 is shaped to provide a hole 42 or other coupling mechanism forcoupling first end 47 of contracting member 30 to the spool, and therebyto contracting mechanism 40. Spool 46 is shaped to define a drivinginterface 48. For some applications, driving interface 48 is female. Forexample, the interface may be shaped to define a channel which extendsthrough the cylindrical portion of spool 46 from an opening provided byan upper surface 50 of spool 46 to an opening provided by a lowersurface 52 of spool 46. Alternatively, driving interface 48 is shaped soas to define an indentation (e.g., a groove) that does not extendentirely through the cylindrical portion of the spool. Furtheralternatively, driving interface 48 is male, and defines a protrusion,e.g., a hexagonal head or a head having another shape.

A distal portion of a screwdriver tool 80, which is describedhereinbelow with reference to FIGS. 5A-B, engages spool 46 via drivinginterface 48 and rotates spool 46 in response to a rotational forceapplied to the screwdriver. The rotational force applied to thescrewdriver tool rotates spool 46 via the portion of the screwdrivertool that engages driving interface 48 of spool 46.

Spool 46 typically comprises a locking mechanism that prevents rotationof the spool after contracting member 30 has been tightened. Forexample, locking techniques may be used that are described withreference to FIG. 4 of above-mentioned U.S. application Ser. No.12/341,960 to Cabiri.

Alternatively, in an embodiment of the present invention, contractingmechanism 40 is configured to tighten contracting member 30, crimp thecontracting member to hold the contracting member taut, and subsequentlycut the excess length of the contracting member.

FIG. 2 is a schematic longitudinal cross-sectional illustration ofanchor deployment manipulator 24, FIG. 3 is a schematic longitudinalcross-sectional illustration of the anchor deployment manipulatoradvanced into annuloplasty ring 22, and FIG. 4 is a schematiccross-sectional illustration of the anchor deployment manipulatoradvanced into the annuloplasty ring, taken along section IV-IV of FIG.3, in accordance with an embodiment of the present invention. Anchordeployment manipulator 24 is advanced into a lumen of sleeve 26, and,from within the lumen, deploys anchors 38 through a wall of the sleeveand into cardiac tissue, thereby anchoring the sleeve around a portionof the valve annulus. Typically, annuloplasty ring 22 and anchordeployment manipulator 24 are introduced into the heart via a sheath104, as described hereinbelow with reference to FIGS. 6A-I.

In an embodiment of the present invention, at least one of anchors 38 isdeployed from a distal end 60 of manipulator 24 while the distal end ispositioned such that a central longitudinal axis 62 through distal end60 of manipulator 24 forms an angle α (alpha) of between about 45 and 90degrees with the wall of sleeve 26 at the point at which the anchorpenetrates the wall, such as between about 75 and 90 degrees, e.g.,about 90 degrees. (In FIG. 3, a line 64 schematically illustrates theplane tangential to the wall of the sleeve at the anchor-penetrationpoint.) This anchor-penetration point is typically at a portion of thesleeve that extends distally beyond the distal end of outer tube 66 ofdeployment manipulator 24 (which is described hereinbelow), i.e., thatis no longer in contact with the outer surface of outer tube 66.Typically, all of the anchors are deployed at such angles, with thepossible exception of the first anchor deployed near the distal end ofthe sleeve.

For some applications, at least one of anchors 38 is deployed fromdistal end 60 of manipulator 24 while distal end 60 is positioned suchthat longitudinal axis 62 through distal end 60 of manipulator 24 formsan angle β (beta) of between about 45 and 90 degrees (such as betweenabout 75 and 90 degrees, e.g., about 90 degrees) with a line 65 definedby (a) a first point 67 at which the anchor currently being deployedpenetrates the wall of the sleeve and (b) a second point 69 at which amost recently previously deployed anchor penetrates the wall of sleeve26. Typically, all of the anchors are deployed at such angles, with theexception of the first anchor deployed near the distal end of thesleeve.

Typically, the anchors are deployed from distal end 60 of manipulator 24into the cardiac tissue in a direction parallel to central longitudinalaxis 62.

In an embodiment of the present invention, anchor deployment manipulator24 comprises an outer tube 66 and an anchor driver 68 which is at leastpartially positioned within tube 66. Anchor driver 68 comprises anelongated, flexible shaft 70, having at its distal end a driver head 72.Rotation of the anchor driver screws the anchors into the cardiactissue. Each of anchors 38 is shaped so as to define a coupling head 74and a tissue coupling element 76. The anchors are typically rigid.Tissue coupling elements 76 may, for example, be helical or spiral inshape (e.g., having the shape of a corkscrew), as shown in the figures,may comprises screws, or may have other shapes. Coupling heads 74 may beeither male (e.g., a hex or square protrusion) or female (e.g., astraight slot, a hex opening, a Phillips opening, or a Robertsonopening). The use of helical anchors, which are screwed into the cardiactissue, generally minimizes the force that needs to be applied duringdeployment of the anchors into the cardiac tissue. Alternatively, theanchors may comprise staples, clips, spring-loaded anchors, or othertissue anchors described in the references incorporated hereinabove inthe Background section, or otherwise known in the art. For someapplications, outer tube 66 of deployment manipulator 24 is steerable,as known in the catheter art, while for other applications, a separatesteerable tube is provided, as described hereinbelow with reference toFIG. 10 or FIG. 11. To provide steering functionality to deploymentmanipulator, outer tube 66, steerable tube 300 (FIG. 10), or steerabletube 320 (FIG. 11), as the case may be, typically comprises one or moresteering wires, the pulling and releasing of which cause deflection ofthe distal tip of the tube.

In an embodiment of the present invention, each of tissue couplingelements 76 is shaped so as to define a longitudinal axis 78 (shown inFIGS. 1A-B), and is configured to penetrate the cardiac tissue in adirection parallel to longitudinal axis 78. Deployment manipulator 24 isconfigured to deploy tissue coupling element 76 from distal end 60 ofthe manipulator through the wall of sleeve 26 in a direction parallel tolongitudinal axis 78 and parallel to central longitudinal axis 62through distal end 60 of deployment manipulator 24 (shown in FIGS. 2, 3,and 7-10).

For some applications, the plurality of anchors are applied using themanipulator by loading a first one of the anchors onto the anchordriver, and deploying the anchor into the cardiac tissue. The anchordriver is withdrawn from the subject's body (typically while leavingouter tube 66 of the deployment manipulator in place in the sleeve), anda second one of the anchors is loaded onto the anchor driver. The anchordriver is reintroduced into the outer tube of the manipulator, and thesecond anchor is deployed. These steps are repeated until all of theanchors have been deployed. Alternatively, the entire deploymentmanipulator, including the anchor driver, is removed from the body andsubsequently reintroduced after being provided with another anchor.Further alternatively, the deployment manipulator is configured tosimultaneously hold a plurality of anchors, and to deploy them one at atime (configuration not shown).

Typically, the first anchor 38 is deployed most distally in sleeve 26(generally at or within a few millimeters of a distal end 51 of thesleeve), and each subsequent anchor is deployed more proximally, suchthat manipulator 24 is gradually withdrawn in a proximal directionduring the anchoring procedure.

Reference is now made to FIGS. 5A-B, which are schematic illustrationsof screwdriver tool 80 being used to rotate spool 46 of contractingmechanism 40 of ring 22, in accordance with respective embodiments ofthe present invention. Screwdriver tool 80 has a head 82 that is eithermale (e.g., comprising a screwdriver head, having, such as a slot-head,an Allen-head, a Phillips-head, a Robertson-head, or a hex-head) orfemale (e.g., comprising a wrench head, having, for example, a square orhex opening), as appropriate for the driving interface provided.Typically, the screwdriver tool comprises a shaft 84, at least a portionof which is flexible. For some applications, the screwdriver tool isused that is described in above-referenced U.S. patent application Ser.No. 12/341,960, with reference to FIG. 4 thereof. Alternatively, anchordriver 68 of deployment manipulator 24 serves as screwdriver tool 80,and is used to rotate the spool, in which case driving interface 48 isappropriately shaped to receive driver head 72 of anchor driver 68.

In the configuration shown in FIG. 5A, contracting member 30 is coupledto distal end 51 of sleeve 26, as shown hereinabove in FIGS. 1A and 3.Contracting mechanism 40 is oriented such that driving interface 48thereof is accessible from within sleeve 26. Screwdriver tool 80 isinserted into sleeve 26, and used to rotate spool 46 via the drivinginterface. Alternatively, anchor driver 68 of deployment manipulator 24serves as screwdriver tool 80, and is used to rotate the spool, in whichcase driving interface 48 is appropriately shaped to engage driver head72 of anchor driver 68. In either case, the sleeve thus serves to guidethe screwdriver tool to driving interface 48. For some applications, aninterior surface of the sleeve is tapered near the distal end of thesleeve, to help guide the screwdriver head to the driving interface. Forsome applications, during the implantation procedure, anchor deploymentmanipulator 24 is left slightly inserted into proximal end 49 of sleeve26 after all of anchors 38 have been deployed, in order to facilitatepassage of screwdriver tool 80 into sleeve 26.

In the configuration shown in FIG. 5B, access to driving interface 48 isprovided from outside sleeve 26. For some applications, contractingmechanism 40 comprises a wire 86 that is attached to the mechanism andpasses out of the body of the subject, typically via sheath 104. Inorder to readily bring the screwdriver tool to driving interface 48,screwdriver tool 80 is guided over (as shown) the wire, or alongside thewire (configuration not shown).

For some applications, contracting mechanism 40 is positioned in avicinity of (e.g., within 1 cm of) distal end 51 of sleeve 26, andaccess to driving interface 48 is provided from outside sleeve 26, asdescribed with reference to FIG. 5B (in which the contracting mechanismis positioned in a vicinity of proximal end 49 of the sleeve).

For some applications in which access to driving interface 48 isprovided from outside sleeve 26, the screwdriver tool is initiallyremovably attached to the driving interface, prior to the commencementof the implantation procedure, and is subsequently decoupled from thedriving interface after spool 46 has been rotated. In theseapplications, contracting mechanism 40 may be positioned in a vicinityof distal end 51 or proximal end 49 of sleeve 26, or at an intermediatelocation along the sleeve. Optionally, at least a portion of a shaft ofthe screwdriver tool is positioned within sheath 104, which is describedhereinbelow with reference to FIGS. 6A-I.

Reference is now made to FIGS. 6A-I, which are schematic illustrationsof a procedure for implanting annuloplasty ring 22 to repair a mitralvalve 130, in accordance with an embodiment of the present invention.The procedure is typically performed with the aid of imaging, such asfluoroscopy, transesophageal echo, and/or echocardiography.

The procedure typically begins by advancing a semi-rigid guidewire 102into a right atrium 120 of the patient, as shown in FIG. 6A.

As show in FIG. 6B, guidewire 102 provides a guide for the subsequentadvancement of a sheath 104 therealong and into the right atrium. Oncesheath 104 has entered the right atrium, guidewire 102 is retracted fromthe patient's body. Sheath 104 typically comprises a 14-20 F sheath,although the size may be selected as appropriate for a given patient.Sheath 104 is advanced through vasculature into the right atrium using asuitable point of origin typically determined for a given patient. Forexample:

-   -   sheath 104 may be introduced into the femoral vein of the        patient, through an inferior vena cava 122, into right atrium        120, and into a left atrium 124 transseptally, typically through        the fossa ovalis;    -   sheath 104 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into right atrium        120, and into left atrium 124 transseptally, typically through        the fossa ovalis; or    -   sheath 104 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into        right atrium 120, and into left atrium 124 transseptally,        typically through the fossa ovalis.

In an embodiment of the present invention, sheath 104 is advancedthrough an inferior vena cava 122 of the patient (as shown) and intoright atrium 120 using a suitable point of origin typically determinedfor a given patient.

Sheath 104 is advanced distally until the sheath reaches the interatrialseptum.

As shown in FIG. 6D, a resilient needle 106 and a dilator (not shown)are advanced through sheath 104 and into the heart. In order to advancesheath 104 transseptally into left atrium 124, the dilator is advancedto the septum, and needle 106 is pushed from within the dilator and isallowed to puncture the septum to create an opening that facilitatespassage of the dilator and subsequently sheath 104 therethrough and intoleft atrium 124. The dilator is passed through the hole in the septumcreated by the needle. Typically, the dilator is shaped to define ahollow shaft for passage along needle 106, and the hollow shaft isshaped to define a tapered distal end. This tapered distal end is firstadvanced through the hole created by needle 106. The hole is enlargedwhen the gradually increasing diameter of the distal end of the dilatoris pushed through the hole in the septum.

The advancement of sheath 104 through the septum and into the leftatrium is followed by the extraction of the dilator and needle 106 fromwithin sheath 104, as shown in FIG. 6E.

As shown in FIG. 6F, annuloplasty ring 22 (with anchor deploymentmanipulator 24 therein) is advanced through sheath 104 into left atrium124.

As shown in FIG. 6G, distal end 51 of sleeve 26 is positioned in avicinity of a left fibrous trigone 142 of an annulus 140 of mitral valve130. (It is noted that for clarity of illustration, distal end 51 ofsleeve 26 is shown schematically in the cross-sectional view of theheart, although left trigone 142 is in reality not located in the showncross-sectional plane, but rather out of the page closer to the viewer.)Alternatively, the tip is positioned in a vicinity of a right fibroustrigone 144 of the mitral valve (configuration not shown). Furtheralternatively, the distal tip of the sleeve is not positioned in thevicinity of either of the trigones, but is instead positioned elsewherein a vicinity of the mitral valve, such as in a vicinity of the anterioror posterior commissure. For some applications, outer tube 66 of anchordeployment manipulator 24 is steerable, as is known in the catheter art,while for other applications, a separate steerable tube is provided, asdescribed hereinbelow with reference to FIG. 10 and FIG. 11. In eithercase, the steering functionality typically allows the area near thedistal end of the manipulator to be positioned with six degrees offreedom. Once positioned at the desired site near the selected trigone,manipulator 24 deploys a first anchor 38 through the wall of sleeve 26into cardiac tissue near the trigone.

As shown in FIG. 6H, deployment manipulator 24 is repositioned alongannulus 140 to another site selected for deployment of a second anchor38. Typically, the first anchor is deployed most distally in the sleeve(generally at or within a few millimeters of the distal tip of thesleeve), and each subsequent anchor is deployed more proximally, suchthat the manipulator is gradually withdrawn in a proximal directionduring the anchoring procedure. The already-deployed first anchor 38holds the anchored end of sleeve 26 in place, so that the sleeve isdrawn from the site of the first anchor towards the site of the secondanchor. Deployment manipulator 24 deploys the second anchor through thewall of the sleeve into cardiac tissue at the second site. Depending onthe tension applied between the first and second anchor sites, theportion of sleeve 26 therebetween may remain tubular in shape, or maybecome flattened, which may help reduce any interference of the ringwith blood flow.

For some applications, in order to provide the second and subsequentanchors, anchor driver 68 is withdrawn from the subject's body viasheath 104 (typically while leaving outer tube 66 of the deploymentmanipulator in place in the sleeve), provided with an additional anchor,and then reintroduced into the subject's body and into the outer tube.Alternatively, the entire deployment manipulator, including the anchordriver, is removed from the body and subsequently reintroduced uponbeing provided with another anchor. Further alternatively, deploymentmanipulator 24 is configured to simultaneously hold a plurality ofanchors, and to deploy them one at a time at the selected sites.

As shown in FIG. 6I, the deployment manipulator is repositioned alongthe annulus to additional sites, at which respective anchors aredeployed, until the last anchor is deployed in a vicinity of rightfibrous trigone 144 (or left fibrous trigone 142 if the anchoring beganat the right trigone). Alternatively, the last anchor is not deployed inthe vicinity of a trigone, but is instead deployed elsewhere in avicinity of the mitral valve, such as in a vicinity of the anterior orposterior commissure.

As described hereinabove with reference to FIGS. 1A and 1B, ascrewdriver tool or anchor driver 68 of deployment manipulator 24 isused to rotate spool 46 of contracting mechanism 40, in order to tightenring 22. (For clarity of illustration, contracting member 30 of ring 22,although provided, is not shown in FIGS. 6A-I.) Alternatively, anothertechnique is used to tighten the ring, such as described hereinabove.

For some applications, sleeve 26 is filled with a material (e.g.,polyester, polytetrafluoroethylene (PTFE), polyethylene terephthalate(PET), or expanded polytetrafluoroethylene (ePTFE)) after beingimplanted. The material is packed within at least a portion, e.g., 50%,75%, or 100%, of the lumen of sleeve 26. The filler material functionsto prevent (1) formation within the lumen of sleeve 26 of clots or (2)introduction of foreign material into the lumen which could obstruct thesliding movement of contracting member 30.

For some applications, proximal end 49 of sleeve 26 is closed uponcompletion of the implantation procedure. Alternatively, the proximalend of the sleeve may have a natural tendency to close when not heldopen by manipulator 24.

Reference is made to FIG. 7, which is a schematic illustration of thedeployment of one of anchors 38 into cardiac tissue, in accordance withan embodiment of the present invention. In this embodiment, one or more(such as all) of anchors 38 are deployed from left atrium 124, throughtissue of the atrial wall, and into tissue of an upper region of theventricular wall 150 near the atrium. Because the tissue of the upperregion of ventricular wall is thicker than that of the atrial wall,deploying the anchors into the upper region of the ventricular wallgenerally provides more secure anchoring. In addition, because theanchors are not deployed laterally through the atrial wall, the risk ofperforating the atrial wall is reduced.

Annuloplasty ring 22 may be advanced toward annulus 140 in any suitableprocedure, e.g., a transcatheter procedure, a minimally invasiveprocedure, or an open heart procedure (in which case one or moreelements of system 20 are typically rigid). Regardless of the approach,the procedure typically includes the techniques described hereinabovewith reference to FIGS. 6G-I and 7.

For some applications, following initial contraction of annuloplastyring 22 during the implantation procedure, the ring may be furthercontracted or relaxed at a later time after the initial implantation.Using real-time monitoring, tactile feedback and optionally incombination with fluoroscopic imaging, a screwdriver tool or anchordriver 68 of deployment manipulator 24 is reintroduced into the heartand used to contract or relax annuloplasty ring 22.

Reference is now made to FIG. 8, which is a schematic illustration ofsystem 10 comprising a flexible pusher element 200, in accordance withan embodiment of the present invention. Pusher element 200 aids withaccurately positioning successive anchors 38 during an implantationprocedure, such as described hereinabove with reference to FIGS. 6H and6I. For some applications, pusher element 200 is positioned partiallywithin tube 66 of deployment manipulator 24 such that a distal portion204 of pusher element 200 extends distally out of tube 66, through anopening 206 in a vicinity of a distal end of the tube (e.g., that iswithin 3 mm of the distal end, such as within 2 mm of the distal end). Aproximal portion 202 of pusher element 200 passes through outer tube 66from opening 206 to the proximal end of tube 66. Opening 206 is providedeither through a wall of the tube (as shown in FIG. 8), or through thedistal end of the tube (configuration not shown). Alternatively, pusherelement 200 is positioned within sleeve 26, but outside of tube 66(configuration not shown). Typically, the pusher element is elongated,and is as least as long as sleeve 26.

Pusher element 200 helps move the distal end of deployment manipulator24 from a first site of the annulus at which the manipulator has alreadydeployed a first anchor (e.g., anchor 38A in FIG. 8) to a second sitefor deployment of a second anchor (e.g., anchor 38B), in a directionindicated schematically by an arrow 210. Pusher element 200 is pusheddistally out of opening 206 of tube 66, so that a distal end 212 ofpusher element 200 engages and pushes against an interior surface ofsleeve 26, in a direction indicated schematically by an arrow 214. Theinterior surface of the sleeve may be distal end 51 of the sleeve (asshown), or the wall of the sleeve at a location between distal end 51and opening 206 (not shown). As a result, the distal end of manipulator24 moves in the opposite direction, i.e., as indicated by arrow 210,toward a subsequent anchoring site. The movement in the direction ofarrow 210 is generally along a line or curve defined by the portion ofpusher element 200 already extended between the anchors that havealready been deployed.

For some applications, as manipulator 24 is positioned at successivedeployment sites of the cardiac tissue, pusher element 200 is extendedrespective distances through opening 206, each of which distances issuccessively greater. For other applications, after manipulator 24 ispositioned at each successive deployment site, the pusher element ispulled back in a proximal direction, and again extended a desireddistance in a distal direction, such that the pusher element pushesagain the wall of the sleeve (at a different location on the wall foreach successive relocation of manipulator 24).

This technique thus aids in locating each subsequent anchoring site formanipulator 24. The pusher element may also help control the distancebetween adjacent anchoring sites, because they surgeon may push thepusher element a known distance after deploying each anchor.

Pusher element 200 typically comprises a strip, wire, ribbon, or band,and has a cross-section that is circular, elliptical, or rectangular.Pusher element 200 typically comprises a flexible and/or superelasticmaterial, such as a metal such as nitinol, stainless steel, or cobaltchrome. Distal end 212 of pusher element 200 is dull, so that it doesnot penetrate sleeve 26. For example, the distal end may be folded back,as shown in FIG. 8.

FIG. 9 is a schematic illustration of a pusher tube 250 applied toproximal end 49 of sleeve 26, in accordance with an embodiment of thepresent invention. Pusher tube 250 pushes gently in a distal directionon proximal end 49 of sleeve 26. For example, if, during withdrawal ofouter tube 66 in a proximal direction, the outer tube snags on the wallof sleeve 26 (which, as mentioned above, may comprise braided or wovenfabric), such pushing may help free the snag. For some applications, thetechniques of this embodiment are practiced in combination with those ofthe embodiment described hereinbelow with reference to FIG. 12.(Although in the embodiment described with reference to FIG. 9, system10 typically comprises contracting member 30, for clarity ofillustration the contracting member is not shown in the figure.)

FIG. 10 is a schematic illustration of system 10 comprising a steerabletube 300, in accordance with an embodiment of the present invention. Inthis embodiment, outer tube 66 of deployment manipulator 24 is notsteerable. Instead, to provide steering functionality, deploymentmanipulator 24 comprises a separate steering tube 300, which ispositioned around at least a portion of outer tube 66. Outer tube 66,because it does not provide this steering functionality, may have asmaller diameter than in the embodiment described hereinabove withreference to FIG. 3. Because outer tube 66 has a smaller diameter,sleeve 26 may also have a smaller diameter than in the embodimentdescribed hereinabove with reference to FIG. 3. For some applications,the techniques of this embodiment are practiced in combination withthose of the embodiment described hereinabove with reference to FIG. 9.(Although in the embodiment described with reference to FIG. 10, system10 typically comprises contracting member 30, for clarity ofillustration the contracting member is not shown in the figure.)

FIG. 11 is a schematic illustration of system 10 comprising a steerabletube 320, in accordance with an embodiment of the present invention. Inthis embodiment, outer tube 66 of deployment manipulator 24 is notsteerable. Steering functionality is instead provided by separatesteering tube 320, which is positioned around at least a portion ofshaft 70 of anchor driver 68, and within outer tube 66. For someapplications, the techniques of this embodiment are practiced incombination with those of the embodiment described hereinabove withreference to FIG. 9. (Although in the embodiment described withreference to FIG. 11, system 10 typically comprises contracting member30, for clarity of illustration the contracting member is not shown inthe figure.)

FIG. 12 is a schematic illustration of system 10 comprising a pullingwire 340, in accordance with an embodiment of the present invention. Adistal portion 342 of pulling wire 340 is coupled to proximal end 49 ofsleeve 26, such as by passing through one or more holes near theproximal end. One or more proximal portions 344 of the pulling wire arecoupled to an external control handle 346 of system 10, which ismanipulated by the surgeon outside of the subject's body. Optionally, aportion of deployment manipulator 24 (e.g., a portion of outer tube 66)which is never inserted in sleeve 26 comprises one or more couplingelements 348, such as loops or tubes, through which pulling wire 340passes in order to hold the pulling wire close to the external surfaceof the deployment manipulator.

Pulling wire 340 holds sleeve 26 surrounding deployment manipulator 24.As the pulling wire is released in a distal direction as deploymentmanipulator 24 is withdrawn in a proximal direction, the release of thesleeve allows the sleeve to gradually be removed from around thedeployment manipulator. In FIG. 12, the sleeve is shown partiallyremoved from the manipulator, including the portion of the sleevethrough which one of anchors 38 has been deployed.

For some applications, control handle 346 is configured to releasepulling wire 340 incrementally, such that each time the wire is furtherreleased by a set distance. As a result, the deployment manipulator iswithdrawn from the sleeve by this set distance, andsubsequently-deployed anchors are approximately this set distance apartfrom one another. For example, the handle may comprise a control ring350 that is coupled to proximal portions 344 of the wire, and removablyengages slots 352 on the handle that are spaced apart by this setdistance. Upon completion of the implantation procedure, in order todetach the pulling wire from the sleeve, one end of the wire may be cutor released, and the wire detached from the sleeve by pulling on theother end of the wire.

(Although in the embodiment described with reference to FIG. 12, system10 typically comprises contracting member 30, for clarity ofillustration the contracting member is not shown in the figure.)

Although annuloplasty ring 22 has been described hereinabove ascomprising a partial annuloplasty ring, in some embodiments of thepresent invention, the ring instead comprises a full annuloplasty ring.

In some embodiments of the present invention, system 20 is used to treatan atrioventricular valve other than the mitral valve, i.e., thetricuspid valve. In these embodiments, annuloplasty ring 22 and othercomponents of system 20 described hereinabove as being placed in theleft atrium are instead placed in the right atrium. Althoughannuloplasty ring 22 is described hereinabove as being placed in anatrium, for some application the ring is instead placed in either theleft or right ventricle.

For some applications, techniques described herein are practiced incombination with techniques described in one or more of the referencescited in the Background section of the present patent application.

Additionally, the scope of the present invention described hereinabovewith reference to FIGS. 1A-12 includes embodiments described in thefollowing applications, which are incorporated herein by reference. Inan embodiment, techniques and apparatus described in one or more of thefollowing applications are combined with techniques and apparatusdescribed hereinabove with reference to FIGS. 1A-12:

-   -   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral        Valve treatment techniques,” filed Mar. 15, 2006;    -   U.S. Provisional Patent Application 60/873,075 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;    -   U.S. Provisional Patent Application 60/902,146 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed on Feb. 16,        2007;    -   U.S. Provisional Patent Application 61/001,013 to Gross et al.,        entitled, “Segmented ring placement,” filed Oct. 29, 2007;    -   PCT Patent Application PCT/IL07/001503 to Gross et al.,        entitled, “Segmented ring placement,” filed on Dec. 5, 2007,        which published as PCT Publication WO 08/068756;    -   U.S. Provisional Patent Application 61/132,295 to Gross et al.,        entitled, “Annuloplasty devices and methods of delivery        therefor,” filed on Jun. 16, 2008;    -   U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,        “Adjustable partial annuloplasty ring and mechanism therefor,”        filed on Dec. 22, 2008, which published as US Patent Application        Publication 2010/0161047;    -   U.S. Provisional Patent Application 61/207,908 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed on Feb. 17, 2009;        and    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which published as US Patent        Application Publication 2010/0161041.

FIGS. 13A-B are schematic illustrations of an anchor deployment system420, in accordance with an application of the present invention. Anchordeployment system 420 comprises an anchor deployment tool 430, which isconfigured to deliver a plurality of anchors 432 to respective siteswithin a body of a subject, and to couple the anchors to tissue at thesites. For some applications, tool 430 is configured to deploy anchors432 to cardiac sites within the heart, such as in a vicinity of a valveannulus. Tool 430 comprises a flexible outer tube 434, within which ispositioned a flexible inner shaft 436. Tool 430 further comprises arotating deployment element 438, coupled to a distal shaft end 439 ofinner shaft 436.

As shown in FIG. 13A, tool 430 (e.g., flexible outer tube 434) isconfigured to provide an anchor storage area 440, which is configured toinitially store the plurality of anchors 432. The anchors are positionedwithin outer tube 434 such that inner shaft 436 passes throughrespective longitudinal channels of the anchors, as describedhereinbelow with reference to FIGS. 18A-C. A distal anchor storage end441 of anchor storage area 440 is typically at distance of at least 1 cmfrom a distal tube end 442 of outer tube 434, such as at least 3 cm orat least 5 cm, to enable flexibility and manipulation of the tool end.Distal anchor storage end 441 is typically at a distance of no more than90 cm from distal tube end 442, such as no more than 25 cm, to maintainthe comfort and stability level of the user. For some applications,distal anchor storage end 441 is at a distance of between 3 cm and 25 cmfrom distal tube end 442, such as between 5 cm and 25 cm. Tool 430typically comprises a spring 444, which is arranged to apply adistally-directed force to the proximal-most anchor within anchorstorage area 440, thereby holding the anchors within the storage area,and advancing the remaining anchors distally as each of the anchors isseparately deployed.

The portion of tool 430 between distal anchor storage area end 441 anddistal tube end 442 of outer tube 434 serves as a distal anchormanipulation area 450 of tool 430. Anchor manipulation area 450 istypically flexible and steerable. Typically, only one anchor at a timeis deployed through anchor manipulation area 450 and into the tissue ofthe subject, such that no more than exactly one anchor is within anchormanipulation area 450 at any given time. As a result, anchormanipulation area 450 retains its flexibility. Because the anchors aretypically rigid, when more than one of the anchors are longitudinallycontiguously positioned within tool 430, the area of the tool in whichthe anchors are positioned becomes fairly stiff, substantially losingthe flexibility it would otherwise have. Thus, while anchor storage area440 is fairly rigid, anchor manipulation area 450 remains flexiblebecause it only contains exactly one anchor at a given time. Thestiffness of the area of the tool in which the anchors are positionedalso may enable the user to better control the exact location ofdistal-most anchor 432 currently stored in anchor storage area 440.

The steering functionality of distal anchor manipulation area 450typically allows the area near the distal end of tool 430 to bepositioned with six degrees of freedom. For some applications, flexibleouter tube 434 is configured to provide the steering functionality todistal anchor manipulation area 450. Flexible outer tube 434 comprisesone or more steering wires, the pulling and releasing of which causedeflection of distal tube end 442, using deflection techniques known inthe catheter art. Alternatively or additionally, flexible inner shaft436 is configured to provide the steering functionality to distal anchormanipulation area 450. Flexible inner shaft 436 comprises one or moresteering wires for deflecting the distal end of the inner shaft. Stillfurther alternatively or additionally, a separate flexible tube isprovided for providing the steering functionality. The separate tube ispositioned within flexible outer tube 434 or around the outer tube, andcomprises one or more steering wires for deflecting the distal end ofthe inner shaft. The curvature of the tool may be pre-shaped, orbendable by application of an external force (such as a conventionalcolonoscope) or using an internal or external wire (configuration notshown). For some applications, the steering functionality is provided bya combination of more than one of flexible outer tube 434, flexibleinner shaft 436, and the separate flexible tube, e.g., by (a) flexibleouter tube 434 and flexible inner shaft 436, (b) flexible outer tube 434and the separate flexible tube, (c) flexible inner shaft 436 and theseparate flexible tube, or (d) all of flexible outer tube 434, flexibleinner shaft 436, and the separate flexible tube.

For some applications, an external control handle is provided forcontrolling tool 430. The control handle comprises circuitry formanipulating the steering wires to provide the steering functionality.

For some applications, flexible inner shaft 436 comprises stainlesssteel SS 304, Nitinol, PEEK®, polyester, or another polymer. For someapplications, outer tube 434 comprises stainless steel SS 304, Nitinol,PEEK®, polyester, or another polymer. For some applications, flexibleinner shaft 436 has a diameter of at least 0.8 mm, no more than 3 mm,and/or between 0.8 and 3 mm, such as between 1 and 2 mm. For someapplications, outer tube 434 has an outer diameter of at least 2 mm, nomore than 4 mm, and/or between 2 and 4 mm, e.g., 3 mm or 3.2 mm. Forsome applications, outer tube 434 has an inner diameter of at least 1.5mm, no more than 3.5 mm, and/or between 1.5 and 3.5 mm, e.g., 2.6 mm.

For some applications, anchor deployment tool 430 further comprises ahemostasis valve 480, as shown in FIG. 13B. Hemostasis valve 480minimizes leakage of blood, and entrance of air (thereby reducing therisk of air emboli), during a percutaneous procedure performed usingsystem 420. A proximal end of flexible outer tube 434 is sealinglycoupled to a distal port of valve 480. Inner shaft 436 passes throughvalve 480, which maintains a seal around the inner shaft, while allowingthe inner shaft to slide distally and proximally through the valveduring deployment of anchors 432, as described hereinbelow withreference to FIGS. 16A-D. Valve 480 optionally comprises a side port 482for flushing the system, as is known in the hemostasis valve art. Forother applications, the anchor deployment tool does not comprise thehemostasis valve.

Reference is made to FIGS. 14 and 15A-B, which are schematicillustrations showing the assembly of components of anchor deploymentsystem 420, in accordance with an application of the present invention.Typically, spring 444 is positioned around a proximal portion offlexible inner shaft 436. A distal end 458 of the spring applies a forcein a distal direction against the proximal end of the proximal-mostanchor 432 (right-most in the figures) stored in anchor storage area440. The plurality of anchors 432 are initially positioned end-to-endlongitudinally contiguously around flexible inner shaft 436 withinanchor storage area 440. By way of example, FIG. 14 shows five anchors432. Typically, system 420 is configured to store between 6 and 20anchors 432, such as between 8 and 16 anchors 432.

As shown in the blow-up of FIG. 14, and described in more detailhereinbelow with reference to FIGS. 18A-C, each of anchors 432 comprisesa helical tissue coupling element 460, and a tool-engaging head 462,fixed to one end of the tissue coupling element. Rotating deploymentelement 438 is configured to removably engage tool-engaging head 462, asdescribed in more detail hereinbelow with reference to FIGS. 16A-D and18A-C.

For some applications, tool 430 provides an anchor restraining mechanism470 in a vicinity of distal anchor storage area end 441. Anchorrestraining mechanism 470 is configured to temporarily restrain at leastthe distal-most anchor 432 currently stored in anchor storage area 440from advancing in a distal direction as another one of the anchors isdeployed through anchor manipulation area 450 and into the tissue of thesubject. Optionally, anchor restraining mechanism 470 is also configuredto temporarily restrain at least the distal-most anchor 432 fromwithdrawing in a proximal direction as inner shaft 436 is withdrawn inthe proximal direction to load a subsequent one of the anchors.

For some applications, as shown in the blow-up of FIG. 15A, anchorrestraining mechanism 470 comprises one or more distal tabs 472 fortemporarily restraining the distal-most anchor 432 currently stored inanchor storage area 440 from advancing in the distal direction. Thedistal tabs may be cut out of flexible outer tube 434, as shown, or theymay be provided as separate elements coupled to the outer tube. Thedistal tabs apply a force in a radially-inward direction against adistal portion of anchor 432, gently squeezing against the distalportion. The force is sufficient to prevent distal motion of distal-mostanchor 432 and the other anchors currently stored in anchor storage area440, which otherwise would be advanced distally by the force applied onthe proximal-most anchor 432 by spring 444. However, the force isinsufficient to prevent distal advancement of distal-most anchor 432when the anchor is engaged and advanced distally by rotating deploymentelement 438, as described hereinbelow with reference to FIGS. 16A-B. Forsome applications, anchor restraining mechanism 470 comprises two distaltabs 472, typically on opposite sides of the outer tube (typicallyaxially aligned with each other), as shown, while for otherapplications, the anchor restraining mechanism comprises exactly onedistal tab, or three or more distal tabs, e.g., three or four distaltabs (typically axially aligned with one another).

For some applications, anchor restraining mechanism 470 comprises a set473 of one or more proximal tabs 474 for temporarily restraining thedistal-most anchor 432 currently stored in anchor storage area 440 fromwithdrawing in the proximal direction. The proximal tabs may be cut outof flexible outer tube 434, as shown, or they may be provided asseparate elements coupled to the outer tube. The distal ends of theproximal tabs engage the proximal end of the tool-engaging head ofdistal-most anchor 432. For some applications, set 473 comprises twoproximal tabs 474, typically on opposite sides of the outer tube(typically axially aligned with each other), as shown, while for otherapplications, the set comprises exactly one proximal tab, or three ormore proximal tabs, e.g., three or four proximal tabs (typically axiallyaligned with one another).

Reference is made to FIGS. 16A-D, which are schematic illustrations ofthe deployment of a single one of anchors 432 into tissue using anchordeployment tool 430, in accordance with an application of the presentinvention. As shown in FIG. 16A, the anchor to be deployed is thedistal-most one of the anchors stored in anchor storage area 440, and isinitially restrained in the anchor storage area by anchor restrainingmechanism 470. Flexible inner shaft 436 is advanced in a distaldirection until rotating deployment element 438 directly engagestool-engaging head 462 of the anchor (by “directly engages,” it is meantthat rotating deployment element 438 comes in direct contact with theanchor, rather than indirect contact via one or more of the otheranchors). Rotating deployment element 438 assumes its radially-expandedstate, as described hereinbelow with reference to FIG. 19A, to enablethis engagement.

As shown in FIG. 16B, flexible inner shaft 436 is advanced in the distaldirection, until rotating deployment element 438 brings the anchor intocontact with tissue 490 of a subject at a first site. For example, thetissue may be cardiac tissue. Typically, anchor deployment tool 430 isconfigured such that, as rotating deployment element 438 advances eachof the anchors in the distal direction, only the single anchor 432currently being advanced is within distal anchor manipulation area 450.Rotating deployment element 438 is rotated, in order to screw helicaltissue coupling element 460 of the anchor into the tissue. For someapplications, rotating deployment element 438 is rotated by rotatingflexible inner shaft 436. For other applications, rotating deploymentelement 438 is rotated by rotating an additional rotation shaft providedwithin flexible inner shaft 436, which additional shaft is coupled torotating deployment element 438. Rotation of rotating deployment element438 typically rotates only the anchor currently engaged by thedeployment element, while the other anchors still stored in the storagearea typically are not rotated.

Typically, anchor 432 is deployed from distal tube end 442 of outer tube434 of tool 430 into cardiac tissue 490 in a direction parallel to acentral longitudinal axis 492 of outer tube 434 through distal tube end442, and/or parallel to central longitudinal axis 500 of anchor 432, asdescribed hereinbelow with reference to FIGS. 18A-C.

Also as shown in FIG. 16B, the evacuation of the distal-most anchor fromanchor restraining mechanism 470 frees up the anchor restrainingmechanism for the next distal-most anchor remaining in anchor storagearea 440. Spring 444 distally advances all of anchors 432 remaining inanchor storage area 440, until the next distal-most anchor is positionedwithin anchor restraining mechanism 470.

As shown in FIG. 16C, after the anchor has been coupled to tissue 490,rotating deployment element 438 is disengaged from the anchor bywithdrawing the rotating deployment element in a proximal direction. Asthe rotating deployment element passes through the next anchor in theproximal direction, the rotating deployment element is squeezed by theengaging opening of tool-engaging head 462 of the next anchor, causingthe rotating deployment element to assume its radially-compressed state,as described hereinbelow with reference to FIG. 19B.

As shown FIG. 16D, anchor deployment tool 430 is repositioned to deploya second anchor 432 at a second site of tissue 490, different from thefirst site. Such repositioning is typically accomplished using thesteering functionality of distal anchor manipulation area 450, asdescribed hereinabove. The steps of the deployment method are repeated,until as many anchors 432 as desired have been deployed, at respectivesites, e.g., a first site, a second site, a third site, a fourth site,etc.

Reference is made to FIGS. 17A-B, which are schematic illustrations ofan alternative configuration of anchor deployment system 420, inaccordance with an application of the present invention. In thisconfiguration, anchor restraining mechanism 470 typically comprises oneor more distal tabs 472, as in the configuration described hereinabovewith reference to FIGS. 14, 15A-B, and 16A-D. Unlike in theconfiguration described hereinabove with reference to FIGS. 14, 15A-B,and 16A-D, in this configuration anchor restraining mechanism 470comprises a plurality of sets 473 of proximal tabs 474, labeled 473A,473B, 473C, . . . in FIGS. 17A-B. Each set of proximal tabs 474 engagesexactly one anchor 432. For example, the distal ends of proximal tabs474 of set 473A engage the proximal end of the tool-engaging head ofdistal-most anchor 432, and the distal ends of proximal tabs 474 of set473B engage the proximal end of the tool-engaging head ofsecond-to-distal-most anchor 432.

Sets 473 thus provide respective anchor storage locations. Therefore,the anchor restraining mechanism comprises a number of sets 473 greaterthan or equal to the number of anchors 432 initially stored in anchorstorage area 440. For some applications, anchor restraining mechanism470 comprises between 6 and 20 sets 473, such as between 8 and 16 sets473. For some applications, each of sets 473 comprises two proximal tabs474, typically on opposite sides of the outer tube (typically axiallyaligned with each other), as shown, while for other applications, eachof the sets comprises exactly one proximal tab, or three or moreproximal tabs, e.g., three or four proximal tabs (typically axiallyaligned with one another).

For some applications, each of sets 473 (except the proximal-most set473) additionally functions as a distal tab 472 for the anchorproximally adjacent to the set. For example, set 473A, in addition toengaging distal-most anchor 432A, also prevents distal motion ofsecond-to-distal-most anchor 432.

Unlike in the configuration described hereinabove with reference toFIGS. 14, 15A-B, and 16A-D, in the present configuration each of anchors432 remains in place in its initial, respective anchor storage locationin anchor storage area 440, until the anchor is individually advancedout of anchor storage area 440 during deployment by anchor deploymenttool 430. Spring 444 is thus typically not provided in thisconfiguration. Deployment of the anchors is typically performed asdescribed hereinabove with reference to FIGS. 16A-D, except:

-   -   at the step described with reference to FIG. 16B, spring 444        does not distally advance the remaining anchors (as mentioned        above, spring 444 is typically not provided in this        configuration); and    -   at the step described with reference to FIG. 16C, anchor        deployment tool 430 is withdrawn further proximally, until the        anchor deployment tool reaches the next remaining anchor 432 in        anchor storage area 440. The next anchor, as mentioned above,        has remained in its original location even after deployment of        more distally positioned anchor(s) 432.

Reference is now made to FIGS. 18A-C, which are schematic illustrationsof one of anchors 432 from three different views, in accordance with anapplication of the present invention. As described above, each ofanchors 432 comprises helical tissue coupling element 460, andtool-engaging head 462, fixed to one end of the tissue coupling element(the proximal end of the tissue coupling element, opposite the distalend that first penetrates the tissue). Anchor 432 comprises a hardmaterial, such as metal, e.g., steel, Nitinol, or stainless steelSS316LVM. Anchor 432 may be manufactured from a single piece ofmaterial, or coupling element 460 and tool-engaging head 462 may bemanufactured from separate pieces of material and fixed together.

Typically, helical tissue coupling element 460 has an inner diameter D1of at least 1.5 mm, no more than 2.5 mm, and/or between 1.5 and 2.5 mm,e.g., 1.8 mm, along an entire length thereof along a centrallongitudinal axis 500 of anchor 432 (although inner diameter D1 is shownas being constant along the entire length of coupling element 460, theinner diameter optionally varies along the length of the couplingelement). Inner diameter D1 is sufficiently large to allow passagethrough helical tissue coupling element 460 of flexible inner shaft 436and rotating deployment element 438, optionally even when rotatingdeployment element 438 is in its radially-expanded state, as describedhereinbelow with reference to FIG. 19A. An outer diameter D2 of helicaltissue coupling element 460 may be, for example, at least 2.4 mm, nomore than 5 mm, and/or between 2.4 and 5 mm, e.g., 2.4 mm.

Tool-engaging head 462 is shaped so as to define an engaging opening 502that passes entirely through the tool-engaging head along axis 500. Theengaging opening is typically at least partially non-circular, in orderto engage rotating deployment element 438. For example, as shown inFIGS. 18A-C, engaging opening 502 may be shaped so as to define aproximal non-circular internal engaging surface 466, and a distalcircular non-engaging surface 464. Proximal engaging surface 466 isshaped to engage rotating deployment element 438, such that rotation ofthe deployment element rotates tool-engaging head 462 and anchor 432.For example, proximal engaging surface 466 may be rectangular (e.g.,square), teethed (e.g., defining a plurality of squares with whichrotating element 438 can engage, for applications in which engagingelements 520A and 520B together have a square cross-sectional shape),star-shaped, polygonal (e.g., octagonal), or any other appropriatenon-circular shape.

A portion of deployment element 438 may pass partially or completelythrough distal non-engaging surface 464, without engaging this surface.The non-engaging surface may serve as a shoulder, which pushes againsttissue 490, providing resistance when the anchor has been sufficientlyscrewed into the tissue. Optionally, deployment element 438 does notpass entirely through distal non-engaging surface 464, such that thedeployment element does not press against or into the tissue.Alternatively, the deployment element may protrude slightly from thedistal non-engaging surface 464, as shown in FIGS. 20A-B, when no forceis applied to the deployment element by the tissue. Optionally, when theanchor is pressed against the tissue, inner spaces in thetool-engagement head 462 of the anchor allow the deployment element tosink into the anchor, and not press against the tissue.

Engaging opening 502 typically has a cross-sectional area (perpendicularto axis 500) of at least 0.8 mm2, such as at least 1.2 mm2. The area issufficient large to allow passage through engaging opening 502 offlexible inner shaft 436 and rotating deployment element 438, when therotating deployment element assumes its radially-compressed state bybeing withdrawn in a proximal direction (from tissue coupling element460 toward tool-engaging head 462), as described hereinbelow withreference to FIG. 19B.

For some applications, the anchor is used to couple a sheet of material,such as a fabric, to tissue 490. For these applications, because thetissue coupling element is fixed near the edge of the tool-engaginghead, the sheet resists further rotation of the anchor once the anchoris fully screwed into the tissue and the tool-engaging head contacts thesheet. Such resistance prevents accidental over-rotation of the anchor,which could tear the tissue or the sheet. In contrast, in anchors inwhich the tissue coupling element is fixed at or near the center of thetool-engaging head, the sheet does not resist rotation of the anchorafter the anchor has been fully screwed into the tissue and thetool-engaging head contacts the sheet. For some applications, thesurgeon or a sensor sense increased resistance to rotation of the tissuecoupling element when the sheet resists the rotation, and, responsivelythe sensed increased resistance, the surgeon ceases rotating the tissuecoupling element into the tissue

For some applications, anchor deployment system 420 comprises atorque-limiting element, as is known for conventional screwdrivers, toprevent over-application of torque. Alternatively or additionally, forsome applications, anchor deployment system 420 comprises a sensor(e.g., a torque transducer), for measuring the resistance to rotation ofanchor 432. When the measured resistance exceeds a threshold value, thesystem generates a signal alerting the surgeon, and/or discontinuesrotation of inner shaft 436. The increased resistance is typicallycaused by the sheet, as described above, and/or the non-engaging surface(shoulder) of the anchor head, as described above.

For some applications, a proximal-most portion 506 of helical tissuecoupling element 460, at the end which is fixed to tool-engaging head462, is generally straight and oriented generally parallel to axis 500,i.e., at angle of between 0 and 15 degrees with the axis, such as 0degrees. Proximal-most portion 506 typically has a length of between 0.5and 2 mm, such as about 1 mm.

The outer perimeter of tool-engaging head 462 is typically circular, andan outer diameter D3 of tool-engaging head 462 may be, for example, atleast 2 mm, no more than 7 mm, and/or between 2 and 7 mm, such asbetween 2.5 and 5 mm, e.g., 2.4 mm, 2.5 mm, or 3 mm.

The outer diameter of anchor 432 is typically equal to outer diameter D3of tool-engaging head 462, or, alternatively, to outer diameter D2 ofcoupling element 460. The outer diameter of anchor 432 may be, forexample, at least 2 mm, no more than 7 mm, and/or between 2 and 7 mm,such as between 2.5 and 5 mm. The entire length of anchor 432, measuredalong axis 500, is typically at least 2.5 mm, no more than 6 mm, and/orbetween 2.5 and 6 mm, such as between 3 and 4.5 mm.

The proximal end of tissue coupling element 460 is typically fixed totool-engaging head 462 near the outer perimeter of the tool-engaginghead, such that the tissue coupling element does not block engagingopening 502. For example, as labeled in the top-view of the anchor inFIG. 18C, the tissue coupling element may be fixed to the tool-engaginghead such that one or more of the following dimension characterize theanchor:

-   -   a distance D5 between (a) a center 510 of the proximal end of        tissue coupling element 460 and (b) an outer perimeter of        tool-engaging head 462 is no more than 20% of a width D3 of        tool-engaging head 462 (the width is a diameter for applications        in which the head is circular), such as no more than 10% of        width D3. For example, distance D5 may be between 0.1 and 0.3        mm, e.g., 0.2 mm;    -   a distance D6 between (a) a most radially-inward portion 512 of        the proximal end of tissue coupling element 460 (i.e., the        portion of the proximal end that is closest to central        longitudinal axis 500 of the anchor) and (b) the outer perimeter        of tool-engaging head 462 is no more than 40% of width D3 of        tool-engaging head 462 (the width is a diameter for applications        in which the head is circular), such as no more than 30% of        width D3, or no more than 20% of width D3. For example, distance        D6 may be between 0.3 and 0.5 mm, e.g., 0.4 mm; and/or    -   a distance between (a) a most radially-outward portion 514 of        the proximal end of tissue coupling element 460 (i.e., the        portion of the proximal end that is furthest from central        longitudinal axis 500 of the anchor) and (b) the outer perimeter        of tool-engaging head 462 is no more than 10% of width D3 of        tool-engaging head 462 (the width is a diameter for applications        in which the head is circular), such as no more than 5% of width        D3, e.g., 0. For example, distance D6 may be between 0 and 0.1        mm, e.g., 0 mm.

Anchor 432, including both helical tissue coupling element 460 andtool-engaging head 462, is thus shaped so as to provide a channel alongthe entire length of the anchor, through which flexible inner shaft 436can pass, and through which rotating deployment element 438 can passwhen in its radially-compressed state, as described hereinabove withreference to FIGS. 13A-4D. More generally, as shown in FIG. 18B, thechannel is sized and shaped such that a right circular cylinder 504could be placed within the channel, coaxial with anchor 432 (i.e., theaxis of the cylinder coincides with central longitudinal axis 500 ofanchor 432), and along the entire length of the tissue anchor, thecylinder having a diameter D4 of at least 1 mm, such as at least 2 mm.Typically, diameter D4 is between 0.05 and 1 mm greater than diameter D3of tool-engaging head 462. It is to be understood that cylinder 504 isan abstract geometric shape, rather than an element of an embodiment ofthe invention, and, as such, is perfectly cylindrical, i.e., is notshaped so as to define any grooves or other surface or internalanomalies. No portion of anchor 432 intersects central longitudinal axis500.

Reference is made to FIGS. 19A and 19B, which are schematicillustrations of rotating deployment element 438 in radially-expandedand radially-compressed states, respectively, in accordance with anapplication of the present invention. For some applications, rotatingdeployment element 438 is shaped so as to define at least two prongs524A and 524B that extend in a distal direction from a proximal base 522of the deployment element. Engagement elements 520A and 520B extend in adistal direction from prongs 524A and 524B, respectively. The engagementelements are typically male, and, for example, may together have across-sectional shape that is rectangular, e.g., square. Optionally,rotating deployment element 438 comprises more than two prongs and twoengagement elements, e.g., three or four of each.

Rotating deployment element 438 is typically configured to assume aradially-expanded state as its resting state, as shown in FIG. 19A. Inthis expanded state, engagement elements 520A and 520B, as well asprongs 524A and 524B, are positioned apart from one another. In thisstate, the engagement elements are shaped and sized to engagetool-engaging head 462 of anchor 432, as shown, for example, in FIG.16B.

As shown in FIG. 19B, the rotating deployment element 438 assumes aradially-compressed state, when the engagement elements and prongs aresqueezed together, such as by passing through the engaging opening oftool-engaging head 462 of anchor 432, as described hereinabove withreference to FIG. 16C.

Reference is now made to FIGS. 20A and 20B, which are schematicillustrations of rotating deployment element 438 engaging tool-engaginghead 462 of anchor 432, with the element 438 in locked and unlockedstates, respectively, in accordance with an application of the presentinvention. In accordance with this application, rotating deploymentelement 438 comprises a locking mechanism 528, which is configured toselectively assume locked and unlocked states. When locking mechanism528 assumes the locked state, the locking mechanism preventsdisengagement of rotating deployment element 438 from the anchor whichrotating deployment element 438 currently engages anchor. This lockingallows deployment element 438 to proximally withdraw anchor 432 ifnecessary, without coming disengaged therefrom. Disengagement is thusprevented even upon withdrawal of the rotating deployment element in theproximal direction. When the locking mechanism assumes the unlockedstate, the locking mechanism does not prevent disengagement of therotating deployment element from the anchor upon withdrawal of rotatingdeployment element 438 in the proximal direction. The rotatingdeployment element thus can be disengaged and withdrawn from the anchorin a proximal direction. It is noted that even when the lockingmechanism assumes the unlocked state, the rotating deployment elementgenerally does not disengage from the anchor unless the rotatingdeployment element is withdrawn in the proximal direction. As mentionedabove with reference to FIG. 19A, rotating deployment element 438 istypically configured to assume a radially-expanded state as its restingstate. In this radially-expanded state, engagement elements 520A and520B are positioned apart from each other, and engage tool-engaging head462 of anchor 432.

For some applications, locking mechanism 528 comprises a pin 530. Inorder to cause the locking mechanism to assume the locked position, pin530 is advanced distally between engagement elements 520A and 520B. Thepin holds the engagement elements in their radially-expanded state, asdescribed hereinabove with reference to FIG. 19A, thereby preventing theengagement elements from assuming the radially-compressed state shown inFIG. 19B and disengaging from the anchor. In the radially-expandedstate, the engagement elements engage proximal engaging surface 466 oftool-engaging head 462 of anchor 432. In order to cause lockingmechanism 528 to assume the unlocked state, pin 530 is withdrawnproximally from between engagement elements 520A and 520B. As a result,the engagement elements may assume the radially-compressed state shownin FIG. 19B when deployment element 438 is withdrawn in the proximaldirection. In the radially-compressed state, the engagement elements donot engage the tool-engaging head of the anchor.

Providing this selective, actively-controllable engagement and releaseof the anchor allows rotating deployment element 438 to be used tounscrew an already-deployed anchor from the tissue, and/or to proximallywithdraw an anchor, without deployment element 438 unintentionallydisengaging from the anchor head. Such unscrewing or proximal withdrawalmay allow an anchor to be repositioned if it is initially coupled to thetissue in an incorrect location. Rotating deployment element 438 iscapable of performing this redeployment for both (a) the anchor that hasbeen most recently deployed into the tissue, and to which the deploymentelement 438 is still coupled, and (b) an anchor that was previouslydeployed, and from which deployment element 438 has already beendecoupled (and, optionally, even after another anchor has subsequentlybeen deployed). In the latter case, deployment element 438 re-engagesthe anchor that is to be redeployed.

Reference is now made to FIGS. 21A-I, which are schematic illustrationsof a procedure for implanting an annuloplasty ring 622 to repair amitral valve 630, in accordance with an application of the presentinvention. This procedure is one exemplary procedure that can beperformed using anchor deployment system 420.

Annuloplasty ring 622 is used to repair a dilated valve annulus of anatrioventricular valve, such as mitral valve 630. For some applications,the annuloplasty ring is configured to be placed only partially aroundthe valve annulus (e.g., to assume a C-shape), and, once anchored inplace, to be contracted so as to circumferentially tighten the valveannulus. The annuloplasty ring comprises a flexible sleeve 626 and aplurality of anchors 432. Anchor deployment tool 430 is advanced into alumen of sleeve 626, and, from within the lumen, deploys the anchorsthrough a wall of the sleeve and into cardiac tissue, thereby anchoringthe sleeve around a portion of the valve annulus. For some application,annuloplasty ring 622 is implemented using techniques described in U.S.application Ser. No. 12/437,103, filed May 7, 2009, and/or U.S.application Ser. No. 12/689,635, filed Jan. 19, 2010, both of which areassigned to the assignee of the present application and are incorporatedherein by reference. For some application, annuloplasty ring 622comprises a contracting mechanism 640. The contracting mechanismcomprises a rotatable structure, such as a spool, arranged such thatrotation of the rotatable structure contracts the implant structure. Theimplant further comprises a longitudinal member, such as a wire, whichis coupled to the contracting mechanism. A rotation tool is provided forrotating the rotatable structure. The tool is configured to be guidedalong (e.g., over, alongside, or through) the longitudinal member, toengage the rotatable structure, and to rotate the rotatable structure inresponse to a rotational force applied to the tool.

As shown in FIG. 21A, the procedure typically begins by advancing asemi-rigid guidewire 602 into a right atrium 620 of the patient. Theprocedure is typically performed with the aid of imaging, such asfluoroscopy, transesophageal echo, and/or echocardiography.

As show in FIG. 21B, guidewire 602 provides a guide for the subsequentadvancement of a sheath 604 therealong and into the right atrium. Oncesheath 604 has entered the right atrium, guidewire 602 is retracted fromthe patient's body. Sheath 604 typically comprises a 14-20 F sheath,although the size may be selected as appropriate for a given patient.Sheath 604 is advanced through vasculature into the right atrium using asuitable point of origin typically determined for a given patient. Forexample:

-   -   sheath 604 may be introduced into the femoral vein of the        patient, through an inferior vena cava 623, into right atrium        620, and into a left atrium 624 transseptally, typically through        the fossa ovalis;    -   sheath 604 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into right atrium        620, and into left atrium 624 transseptally, typically through        the fossa ovalis; or    -   sheath 604 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into        right atrium 620, and into left atrium 624 transseptally,        typically through the fossa ovalis.

For some applications of the present invention, sheath 604 is advancedthrough inferior vena cava 623 of the patient (as shown) and into rightatrium 6 using a suitable point of origin typically determined for agiven patient.

Sheath 604 is advanced distally until the sheath reaches the interatrialseptum, and guidewire 602 is withdrawn, as shown in FIG. 21C.

As shown in FIG. 21D, a resilient needle 606 and a dilator (not shown)are advanced through sheath 604 and into the heart. In order to advancesheath 604 transseptally into left atrium 624, the dilator is advancedto the septum, and needle 606 is pushed from within the dilator and isallowed to puncture the septum to create an opening that facilitatespassage of the dilator and subsequently sheath 604 therethrough and intoleft atrium 624. The dilator is passed through the hole in the septumcreated by the needle. Typically, the dilator is shaped to define ahollow shaft for passage along needle 606, and the hollow shaft isshaped to define a tapered distal end. This tapered distal end is firstadvanced through the hole created by needle 606. The hole is enlargedwhen the gradually increasing diameter of the distal end of the dilatoris pushed through the hole in the septum.

The advancement of sheath 604 through the septum and into the leftatrium is followed by the extraction of the dilator and needle 606 fromwithin sheath 604, as shown in FIG. 21E.

As shown in FIG. 21F, annuloplasty ring 622 (with anchor deployment tool430 therein) is advanced through sheath 604 into left atrium 624.

As shown in FIG. 21G, a distal end 651 of sleeve 626 is positioned in avicinity of a left fibrous trigone 642 of an annulus 643 of mitral valve630. (It is noted that for clarity of illustration, distal end 651 ofsleeve 626 is shown schematically in the cross-sectional view of theheart, although left trigone 642 is in reality not located in the showncross-sectional plane, but rather out of the page closer to the viewer.)Alternatively, the tip is positioned in a vicinity of a right fibroustrigone 644 of the mitral valve (configuration not shown). Furtheralternatively, the distal tip of the sleeve is not positioned in thevicinity of either of the trigones, but is instead positioned elsewherein a vicinity of the mitral valve, such as in a vicinity of the anterioror posterior commissure. The steering functionality of anchormanipulation area 450 typically allows the area near the distal end ofthe deployment tool to be positioned with six degrees of freedom. Oncepositioned at the desired site near the selected trigone, deploymenttool 430 deploys a first anchor 432 through the wall of sleeve 626 intocardiac tissue near the trigone, using the techniques describedhereinabove with reference to FIGS. 16A-C.

As shown in FIG. 21H, deployment tool 430 is repositioned along annulus643 to another site selected for deployment of a second anchor 432.Typically, the first anchor is deployed most distally in the sleeve(generally at or within a few millimeters of the distal tip of thesleeve), and each subsequent anchor is deployed more proximally, suchthat the sleeve is gradually pulled off (i.e., withdrawn from) thedeployment tool in a distal direction during the anchoring procedure.The already-deployed first anchor 432 holds the anchored end of sleeve626 in place, so that the sleeve is drawn from the site of the firstanchor towards the site of the second anchor. Typically, as the sleeveis pulled off (i.e., withdrawn from) the deployment tool, the deploymenttool is moved generally laterally along the cardiac tissue, as shown inFIG. 21H. Deployment tool 430 deploys the second anchor through the wallof the sleeve into cardiac tissue at the second site. Depending on thetension applied between the first and second anchor sites, the portionof sleeve 626 therebetween may remain tubular in shape, or may becomeflattened, which may help reduce any interference of the ring with bloodflow.

The techniques described hereinabove with reference to FIG. 16D,followed again by those described with reference to FIGS. 16A-C, areused to provide and deploy the second and subsequent anchors one at atime at the selected sites, respectively.

As shown in FIG. 21I, deployment tool 430 is repositioned along theannulus to additional sites, at which respective anchors are deployed,until the last anchor is deployed in a vicinity of right fibrous trigone644 (or left fibrous trigone 642 if the anchoring began at the righttrigone). Alternatively, the last anchor is not deployed in the vicinityof a trigone, but is instead deployed elsewhere in a vicinity of themitral valve, such as in a vicinity of the anterior or posteriorcommissure. A rotation tool or anchor driver is used to rotate the spoolof contracting mechanism 640, in order to tighten ring 622.

Alternatively, annuloplasty ring 622 is implanted by right or leftthoracotomy, mutatis mutandis.

For some applications of the present invention, annuloplasty ring 622 isused to treat an atrioventricular valve other than the mitral valve,i.e., the tricuspid valve. For these applications, ring 622 and othercomponents of system 420 described hereinabove as being placed in theleft atrium are instead placed in the right atrium. Althoughannuloplasty ring 622 is described hereinabove as being placed in anatrium, for some application the ring is instead placed in either theleft or right ventricle.

In an application of the present invention, anchor deployment system 420is used in combination with mitral valve repair system 400, describedwith reference to FIGS. 17A-F, 18A-B, 19A-E, and 20A-B of InternationalApplication PCT/IL2009/000593, filed Jun. 15, 2009, which published asPCT Publication WO 10/004546, and which is incorporated herein byreference. Instead of passing anchors through the lumen of the catheterfrom a site outside the body of the patient, as described with referenceto FIG. 20B, the anchors are stored in anchor storage area 440 of anchordeployment tool 430.

For some applications, techniques described hereinabove with referenceto FIGS. 13A-21I are practiced in combination with techniques describedin one or more of the references cited in the Background section of thepresent patent application.

Additionally, the scope of the present invention described hereinabovewith reference to FIGS. 13A-21I includes embodiments described in thefollowing applications, which are incorporated herein by reference. Inan embodiment, techniques and apparatus described in one or more of thefollowing applications are combined with techniques and apparatusdescribed hereinabove with reference to FIGS. 13A-21I:

-   -   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral        Valve treatment techniques,” filed Mar. 15, 2006;    -   U.S. Provisional Patent Application 60/873,075 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;        10    -   U.S. Provisional Patent Application 60/902,146 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Feb. 16,        2007;    -   U.S. Provisional Patent Application 61/001,013 to Gross et al.,        entitled, “Segmented ring placement,” filed Oct. 29, 2007;    -   PCT Patent Application PCT/IL07/001503 to Gross et al.,        entitled, “Segmented ring placement,” filed Dec. 5, 2007, which        published as PCT Publication WO 2008/068756;    -   U.S. patent application Ser. No. 11/950,930 to Gross et al.,        entitled, “Segmented ring placement,” filed Dec. 5, 2007, which        published as US Patent Application Publication 2008/0262609;    -   U.S. Provisional Patent Application 61/132,295 to Gross et al.,        entitled, “Annuloplasty devices and methods of delivery        therefor,” filed Jun. 16, 2008;    -   U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,        “Adjustable partial annuloplasty ring and mechanism therefor,”        filed Dec. 22, 2008, which issued as U.S. Pat. No. 8,241,351;    -   U.S. Provisional Patent Application 61/207,908 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed Feb. 17, 2009;    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed May 4, 2009, which issued as U.S. Pat. No.        8,147,542;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        May 7, 2009, which issued as U.S. Pat. No. 8,715,342;    -   PCT Patent Application PCT/IL2009/000593 to Gross et al.,        entitled, “Annuloplasty devices and methods of delivery        therefor,” filed Jun. 15, 2009, which published as PCT        Publication WO 10/004546;    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed        Aug. 27, 2009, which issued as U.S. Pat. No. 8,808,368;    -   U.S. patent application Ser. No. 12/608,316 to Miller et al.,        entitled, “Tissue anchor for annuloplasty ring,” filed Oct. 29,        2009, which issued as U.S. Pat. No. 8,277,502;    -   U.S. Provisional Patent Application 61/265,936 to Miller et al.,        entitled, “Delivery tool for implantation of spool assembly        coupled to a helical anchor,” filed Dec. 2, 2009;    -   PCT Patent Application PCT/IL2009/001209 to Cabiri et al.,        entitled, “Adjustable annuloplasty devices and mechanisms        therefor,” filed Dec. 22, 2009, which published as PCT        Publication WO 2010/073246;    -   U.S. patent application Ser. No. 12/689,635 to Zipory et al.,        entitled, “Over-wire rotation tool,” filed Jan. 19, 2010, which        issued as U.S. Pat. No. 8,545,553;    -   U.S. patent application Ser. No. 12/689,693 to Hammer et al.,        entitled, “Deployment techniques for annuloplasty ring,” filed        Jan. 19, 2010, which issued as U.S. Pat. No. 8,911,494;    -   U.S. patent application Ser. No. 12/706,868 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed Feb. 17, 2010,        which published as US Patent Application Publication        2010/0211166;    -   PCT Patent Application PCT/IL2010/000357 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed        May 4, 2010, which published as PCT Publication WO 2010/128502;        5    -   PCT Patent Application PCT/IL2010/000358 to Zipory et al.,        entitled, “Deployment techniques for annuloplasty ring and        over-wire rotation tool,” filed May 4, 2010, which published as        PCT Publication WO 10/128503; and/or    -   U.S. Regular application Ser. No. 12/785,717 to Miller et al.,        entitled, “Adjustable artificial chordeae tendineae with suture        loops,” filed May 24, 2010, which issued as U.S. Pat. No.        8,790,394.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. Apparatus comprising: an implantable sleevehaving a wall that is shaped to define a lumen; a plurality of tissueanchors; and an anchor deployment tool, which comprises: (a) a flexibletube, which has a distal tube end, and which defines: (i) an anchorstorage area in which the plurality of tissue anchors are stored beforedeployment thereof, and (ii) a distal anchor manipulation area, which(A) is disposed between the anchor storage area and the distal tube end,(B) has a length of at least 3 cm, and (C) is removably positionablewithin the lumen of the sleeve; and (b) a rotating deployment element,which is positioned within the flexible tube, and is configured to,while the distal anchor manipulation area is disposed within the lumenof the sleeve: (i) directly engage the tissue anchors in the anchorstorage area a single one at a time, (ii) advance each of the tissueanchors, while thus directly engaged, in a distal direction into theanchor manipulation area, and (iii) anchor the sleeve to tissue of asubject by deploying each of the tissue anchors through the distal tubeend, through the wall of the sleeve, and into the tissue, wherein theanchor deployment tool is configured such that only the single anchorbeing advanced at the time by the rotating deployment element is withinthe distal anchor manipulation area that is disposed within the lumen ofthe sleeve.
 2. The apparatus according to claim 1, wherein the distalanchor manipulation area is flexible.
 3. The apparatus according toclaim 1, wherein the anchor deployment tool comprises one or moresteering wires, which are arranged such that pulling and releasing ofthe steering wires cause deflection of the distal tube end, therebyproviding steering functionality to the distal anchor manipulation area.4. The apparatus according to claim 1, wherein the rotating deploymentelement is configured to assume a state in which the rotating deploymentelement is passable through one or more of the tissue anchors withoutengaging the tissue anchors.
 5. The apparatus according to claim 4,wherein the rotating deployment element is configured to assume thestate when withdrawn in a proximal direction within the tube.
 6. Theapparatus according to claim 4, wherein the state is aradially-compressed state, and wherein the rotating deployment elementis configured to assume a radially-expanded state when engaging each ofthe tissue anchors.
 7. The apparatus according to claim 1, wherein theanchor deployment tool is configured to deploy each of the tissueanchors into the tissue in a direction parallel to a centrallongitudinal axis of the tube through the distal tube end, and parallelto a central longitudinal axis of the tissue anchor.
 8. The apparatusaccording to claim 1, wherein the rotating deployment element isconfigured to unscrew an already-deployed tissue anchor from the tissue,withdraw the tissue anchor in a proximal direction, and subsequentlyredeploy the tissue anchor into the tissue.
 9. The apparatus accordingto claim 1, comprising an annuloplasty ring, which comprises theimplantable sleeve.
 10. The apparatus according to claim 1, wherein therotating deployment element is configured to deploy each of the tissueanchors through the distal tube end and into the tissue by rotating onlythe tissue anchor directly engaged by the rotating deployment element,without rotating the tissue anchors stored in the anchor storage area.11. The apparatus according to claim 1, wherein the length of the distalanchor manipulation area is at least 5 cm.
 12. The apparatus accordingto claim 1, wherein the plurality of tissue anchors comprises at least 6tissue anchors.
 13. Apparatus comprising: an implantable sleeve having awall that is shaped to define a lumen; a plurality of tissue anchors;and an anchor deployment tool, which comprises: (a) a flexible tube,which has a distal tube end, and which defines: (i) an anchor storagearea in which the plurality of tissue anchors are stored beforedeployment thereof, and (ii) a distal anchor manipulation area, which(A) is disposed between the anchor storage area and the distal tube end,(B) has a length of at least 3 cm, and (C) is removably positionablewithin the lumen of the sleeve; and (b) a deployment element, which ispositioned within the flexible tube, and is configured to, while thedistal anchor manipulation area is disposed within the lumen of thesleeve: (i) directly engage the tissue anchors in the anchor storagearea a single one at a time, (ii) advance each of the tissue anchors,while thus directly engaged, in a distal direction into the anchormanipulation area, and (iii) anchor the sleeve to tissue of a subject bydeploying each of the tissue anchors through the distal tube end,through the wall of the sleeve, and into the tissue, wherein the anchordeployment tool is configured such that only the single anchor beingadvanced at the time by the deployment element is within the distalanchor manipulation area that is disposed within the lumen of thesleeve.
 14. The apparatus according to claim 13, wherein the distalanchor manipulation area is flexible.
 15. The apparatus according toclaim 13, wherein the anchor deployment tool comprises one or moresteering wires, which are arranged such that pulling and releasing ofthe steering wires cause deflection of the distal tube end, therebyproviding steering functionality to the distal anchor manipulation area.16. The apparatus according to claim 13, wherein the deployment elementis configured to assume a state in which the deployment element ispassable through one or more of the tissue anchors without engaging thetissue anchors.
 17. The apparatus according to claim 16, wherein thedeployment element is configured to assume the state when withdrawn in aproximal direction within the tube.
 18. The apparatus according to claim13, wherein the anchor deployment tool is configured to deploy each ofthe tissue anchors into the tissue in a direction parallel to a centrallongitudinal axis of the tube through the distal tube end, and parallelto a central longitudinal axis of the tissue anchor.
 19. The apparatusaccording to claim 13, comprising an annuloplasty ring, which comprisesthe implantable sleeve.
 20. A method comprising: providing an anchordeployment tool, which includes (a) a flexible tube, which has a distaltube end, and which defines (i) an anchor storage area and (ii) a distalanchor manipulation area, which (A) is disposed between the anchorstorage area and the distal tube end, and (B) has a length of at least 3cm, and (b) a rotating deployment element; providing a plurality oftissue anchors, which are initially stored within the anchor storagearea; and while the rotating deployment element is positioned within theflexible tube and the distal anchor manipulation area is removablydisposed within a lumen defined by a wall of a sleeve, using therotating deployment element to (i) directly engage the tissue anchors inthe anchor storage area a single one at a time, (ii) advance each of thetissue anchors, while thus directly engaged, in a distal direction intothe anchor manipulation area, such that only the single anchor beingadvanced at the time by the rotating deployment element is within thedistal anchor manipulation area that is disposed within the lumen of thesleeve, and (iii) anchor the sleeve to tissue of a subject by deployingeach of the tissue anchors through the distal tube end, through the wallof the sleeve, and into the tissue.